MEDICAL DEVICE GUIDANCE DOCUMENT CLASSIFICATION OF REHABILITATION, PHYSIOTHERAPY AND SPEECH THERAPY DEVICE
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
MDA/GD/00xx
February 2022
First Edition
MEDICAL DEVICE
GUIDANCE DOCUMENT
CLASSIFICATION OF REHABILITATION,
PHYSIOTHERAPY AND SPEECH THERAPY
DEVICE
Medical Device Authority
MINISTRY OF HEALTH MALAYSIAMDA/GD/00xx
Contents Page
Preface iii
1 Introduction………………………………………………………………………. 1
2 Scope………………………………………………………………………….…. 1
3 Terms and definitions…………………………………………………………... 1
4 Classification of Rehabilitation, Physiotherapy or Speech Therapy Device.. 3
iiMDA/GD/00xx
Preface
This Guidance Document was prepared by the Medical Device Authority (MDA) to help
the industry and healthcare professionals in their quest to comply with the Medical Device
Act (Act 737) and the regulations under it.
This Guidance Document shall be read in conjunction with the current laws and
regulations used in Malaysia, which include but not limited to the following-
a) Medical Device Act 2012 (Act 737);
b) Medical Device Regulations 2012.
In this Guidance Document, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission; and
— “can” indicates a possibility or a capability.
Irrespective of the requirements of this Guidance Document, MDA has the right to request
for information or material, or define conditions not specifically described in this document
that is deemed necessary for the purpose of regulatory control.
MDA has put much effort to ensure the accuracy and completeness of this guidance
document. In the event of any contradiction between the contents of this document and
any written law, the latter should take precedence.
MDA reserves the right to amend any part of the guidance document from time to time.
CONTACT INFORMATION
For further information, please contact:
MEDICAL DEVICE AUTHORITY
Ministry of Health Malaysia
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor,
MALAYSIA
Fax: (03) 8230 0200
Email: mdb@mda.gov.my
Website: http://www.mda.gov.my
iiiCLASSIFICATION OF REHABILITATION, PHYSIOTHERAPY AND SPEECH
THERAPY DEVICE
1. Introduction
The definition of medical device is legally binding in the Medical Device Act 2012 (Act
737) and it determines the scope of regulatory control of the product. This definition
differentiates medical devices and not medical device based on clear indication on mode
of action for the product been used for rehabilitation, physiotherapy and speech therapy.
It is the responsibility of the manufacturer to demonstrate that its product is safe and
perform as its intended use based on essential safety and performance criteria for the
medical device.
This document is intended to provide guidance to manufacturers and authorised
representatives on the classification of rehabilitation, physiotherapy and speech therapy
products.
2. Scope
This guidance document specifies the classification differences between medical device
and non medical device for rehabilitation, physiotherapy and speech therapy products.
This document is applicable to establishments, and healthcare facilities dealing
rehabilitation, physiotherapy and speech therapy.
3 Terms and definitions
For the purposes of this document, the terms and definitions in Act 737, the regulations
under it and the following terms and definitions apply.
3.1 Disability
An umbrella term for impairments, limitations of activity and restrictions on participation
resulting from the interaction between people with health conditions and the
environmental barriers they encounter
[Source: Draft MS Prosthetic and orthotic devices - Code of practice]
3.2 Disorder
An illness that disrupts normal physical or mental functions.
A set of problems, which result in causing significant difficulty, distress, impairment
and/or suffering in a person’s daily life. physical or mental conditions that disturb the
regular or normal functions of everyday activities and day to day life. They can take up
a lot of time and complicate the normal functioning of an individual.
13.3 Rehabilitation
A set of interventions designed to optimize functioning and reduce disability in
individuals with health conditions in interaction with their environment
[Source: Draft MS Prosthetic and orthotic devices - Code of practice]
3.4 Therapy
Restoring and compensating for the loss of functioning, and preventing or slowing
deterioration in functioning in every area of a person’s life
3.5 Physiotherapy
Physiotherapy (sometimes referred to as physical therapy) Services to individuals and
populations to develop, maintain and restore maximum movement and functional ability
throughout the lifespan, including in circumstances where movement and function are
threatened by ageing, injury, pain, disease, disorders, conditions or environmental
factors. Functional movement is central to being healthy
[Source: Draft MS Prosthetic and orthotic devices - Code of practice]
3.6 Active medical device for therapy
An active medical device that is intended by the manufacturer to be used on a person,
either alone or in combination with another medical device, to support, modify, replace,
or restore biological functions or structures for the purpose of treating or alleviating an
illness, injury, or handicap
3.7 Intended use/ purpose
The objective intent of the manufacturer regarding the use of a product, process or
service as reflected in the specifications, instructions and information provided by the
manufacturer.
3.8 Manufacturer
As defined in Section 2 of Act 737.
3.9 Medical device
As defined in Section 2 of Act 737.
24 Classification of Rehabilitation, Physiotherapy or Speech Therapy
Device
4.1 General requirements as medical device
The rehabilitation, physiotherapy or speech therapy instrument, apparatus, implement,
machine, appliance, material or other similar or related article intended by the
manufacturer to be used, alone or in combination, for human beings for the purpose of
diagnosis, monitoring, treatment, alleviation of or compensation for an injury; and
investigation, replacement or modification, or support of the anatomy or of a
physiological process will be classified as medical device.
In addition, the software which intended purpose as above is also classified as a medical
device.
The set of interventions designed to optimize functioning and reduce disability in
individuals with health conditions in interaction with their environment may not
considered to be as medical device.
The classification of rehabilitation, physiotherapy or speech therapy device listed in
Appendix 1.
3Appendix 1
DRAFT GUIDANCE DOCUMENT OF REHABILITATION PRODUCTS
PRODUCT NAME DESCRIPTION / PRIMARY INTENDED PURPOSE/ INDICATION MEDICAL REMARKS
DEVICE
Ambulation Training
Parallel Bars (Floor Mounted Parallel Bar with motorized / Constructed for patients undergoing physical therapy for their lower body, these bars help through simulated YES
wooden platform ) walking to get them back on their feet.
Training Stairs (Bariatric Stairs, wheelchair stairs, training Intended for patient therapy or rehabilitation. Specifically intended as a tool to help patient move during physical YES
stool, stairs with platforms, Convertible Stairs) therapy. Essential equipment for rehabilitation of lower extremities can be found here. Space-saving options,
convertible configurations, and adjustable parallel bars are crucial for the facility.
Wheelchair Training Essential equipment for rehabilitation of lower extremities for wheelchair patient YES
Anatomical Chart/Models
Anatomical Chart The charts are ideal complimentary pieces to support the models. Usage for teaching human anatomy, patient, NO
education and medical studies
Anatomical Models Anatomical models provide the perfect vehicle to study and explain the internal and external. Models are specially NO
valuable to doctors, chiropractors, therapists, hospital and schools for medical and health education.
Aromatherapy
Aroma Activities Colour and scent coordinated. Soft, squeezable and great to manipulate for hand exercise. Multi-sensory die - NO
tactile, aromatic and with a bell inside for auditory appeal. Improve emotional and physical well-being as it is
kneaded (helping improve motor skills and co- ordination) and the fragrances can improve mood.
Aroma Diffusers Super soft and super sensory. Tactile, visual and aromatic. The sense of smell promotes visual recognition. This NO
stimulation encourages hand movements to place the diffuser on the correct picture.
Aroma Oils A collection of 12 different aromas to encourage reminiscence and evoke memories amongst a wide range of NO
people. Suitable for a wide range of uses - with the Interactive Aroma Panel, an aroma diffuser, in massage blends
or in the bath. Activate smells, colors, sounds and breezes for aromatic, visual, audible and tactile stimulation.
Band / Tube
Exercise Band and Tubing Economical, lightweight and portable, exercise bands are effective when used alone or with handles/anchors. NO
Specially designed band allows the user to know how much force is being used when exercising. Has been used
for physical therapy and athletic training by clinics, fitness centers and individuals
Exercise Band and Tubing For rehabilitation, physical therapy YESStretch Straps Stretch straps facilitate an effective way to improve flexibility and achieve relief from sore and achy muscles. Helps NO
to stretch a specific muscle or tendon to improve and achieve muscle elasticity, muscle tone, muscle control,
flexibility and range-of-motion
Boards/Pads
Balance boards/pads, Balance trainers. Strengthen and condition the lower body while improving balance, coordination, range-of- motion, body NO
awareness, joint mobility and reaction skills. Can be used for vestibular training, low impact aerobics and exercises.
Foot and Ankle Rehabilitation Boards Adjustable Range-Of-Motion (ROM) and weight training to maximize lower body rehabilitation. YES
Incline Boards Incline boards are used to increase extension in the lower and upper back while stretching the calves. Helps to NO
stretch a specific muscle or tendon to improve and achieve muscle elasticity, muscle tone, muscle control, flexibility
and range-of-motion.
Miscellaneous Balance Boards/Pads (Wobble Board, Rocker Can be used for balance, coordination, ankle and knee strengthening and rehabilitation, ankle range-of-motion YES
Board, Slideboard) and flexibility, core stability, improved posture, and proprioceptive training.
Only to use for rehabilitation, physiotherapy/physical therapy
Multi-Axial Platform System (including Professional Board, Adjustable ROM (range-of-motion) and weight training to maximize lower body rehabilitation YES
Weight Rod, 5-Ball Set)
Quad Boards The quad board provides support by forcing the proper amount of knee (or arm) flexion. The board can be used YES
on a treatment table or floor. Board folds flat when not in use. Each section can be adjusted independently to match
exact femoral and tibial lengths. Adjustability of this quad board allows for the knee to be fixed to any degree.
Transfer Boards Intended for person with a lower extremity disabilities to hold on the transfer board. NO
Upper Body Range-of-Motion (ROM) Exercises (Double Increase upper extremity ROM, strength, coordination and endurance, or improve cognitive and visual skills. For YES
Curved Shoulder Arc, Climbing Board, Horizontal Ring Tree, people with neurological disorders, burns and orthopedic problems
Incline Board, Vertical Ring Tree,Semi- Circular Pegboard,
Pipe Tree)
2Appendix 1
DRAFT GUIDANCE DOCUMENT OF REHABILITATION PRODUCTS
PRODUCT NAME DESCRIPTION / PRIMARY INTENDED PURPOSE/ INDICATION MEDICAL REMARKS
DEVICE
Bedding / Pillow
Bed assist / Bed rope ladder Provides support for getting in and out of bed. Easy to grasp handles can be used for repositioning and turning in NO
bed.
Cervical Neck Pillow Rounded cervical and lumbar roll pillows. The down-like feel of the pillows provides a sense of long-lasting NO
freshness and superior pillow life. Carefully designed and constructed for better sleep
Lumbar Foam Positioning and Support It provides the appropriate support to relieve pain and increase comfort during sleep with the usage of the pillow. NO
Positioning and Support Rolls Rounded cervical and lumbar roll pillows. The down-like feel of the pillows provides a sense of long-lasting NO
freshness and superior pillow life. Carefully designed and constructed for better sleep.
Sleeping Pillows, Cervical Support and Traveller Pillow The sleeping pillows are made with high-resiliency fiber and blended cotton cover. The cervical support has cradles NO
and supports head and neck in any position. It combines comfort with therapeutic benefits of hot/cold therapy and
also ice pack included with the cervical support.
The traveller pillow has a compact size and can fit in suitcase. It can be use while sitting orlying down.
It provides the appropriate support to relieve pain and increase comfort during sleep with the usage of the pillow. It
provides a sense of long-lasting freshness and superior pillow life.
Carefully designed and constructed for better sleep.
Cognitive / Vestibular / Sensory / Motor Therapy
Bubble Tube Intended to draw attention, encourage focus or to distract. Colour, lights and bubbles are visually engaging. NO
Also intended to draw attention, encourage focus or to distract.
Cognitive Therapy Assessment (Dynamic Loewenstein An assessment to provide a therapist with reliable, valid and predictable information upon the assessment of NO Rehabilitation
Occupational Therapy, Cognitive Evaluation / Performance patient's cognitive or social level. chart a course of treatment and trach changes over time. To measure working assessment tool
Test)) memory and executive control function. Ideal for patients with neurological deficits, children with learning disabilities
and brain injury.
Modular fine & gross motor therapy activities (Spiral Maze, improve fine and gross motor skills, activities mimic items used on a daily basis, for those with functional limitations YES
Twisting Bar, Latch & Knob, Adjustable Finger Ladder, of hands, fingers or wrists, improve movement, ROM and quality of life by reinforcing independent day-to-day
Rotation Knob) activities. Ideal for OT, hand therapy and those recovering from stroke or traumatic brain injury
Multi-Sensory Fibre Optics for Sensory Room (Light source of Allows the individual to tailor the sensory room to suit their tastes, seeking out the sensory experiences that they NO
Fibre Optics, Fibre Optic Chandelier, Star Ceiling Circle, Fibre enjoy and find beneficial of the multi-sensory light fibre optics. By nature, relaxing spaces that help to reduce
Optic Ceiling Kit, Fibre Optic Clouds, Ultra Violet Fibre Optics, agitation and anxiety, but they can also engage and delight the user, stimulating reactions and encouraging
Jumbo ‘Bamboo’ Fibre, Fibre Optic UFO, Interactive mats communication. Ideal for sensory stimulation, colour recognition and developing the understanding of cause and
with Fibre Optics) effect.
Vestibular- Sensory Intergration and Movement (Suspension Intended for vestibular and sensory integration therapy. Sensory therapy mostly can improve difficulties associated YES
system, Swing Set) with autism.Massagers (Electric Massager, Percussion Massager, Rotary Chiropractic: 1. NO (massager)
Massager, Point Relief Massager) chiropractic thrust adjustment device for spine and extremities. To be used together for patient treatment using 2. YES
chiropractic method. (only for
Massager (Chiropractic) chiropractic
for chiropractic and/or rehabilitation purposes only )
Mats
Center-fold rest mats Used for more strenuous exercises NO
Exercise Mats A professional exercise mats. Intended for therapeutic workouts, fitness workouts involving tumbling, rehab, yoga, YES Prevent from
Pilates, floor exercises, stretching, mobility and stability. Ideal for individual workouts and for use in fitness centers injury
and therapy clinics.
Exercise Mats (Yoga Mats, Rest Mats) Ideal for gymnastics, for stretching, tumbling, floor exercises, flexibility and strength training. Foam exercise mats NO
that are tough enough for clinic, school and fitness center.
4Appendix 1
DRAFT GUIDANCE DOCUMENT OF REHABILITATION PRODUCTS
PRODUCT NAME DESCRIPTION / PRIMARY INTENDED PURPOSE/ INDICATION MEDICAL REMARKS
DEVICE
Measurement
Goniometer, Inclinometer, Scoliometer Posture evaluation instruments provide accurate and repeatable measurements. Use to measure thoracic and YES
lumbar ROM, lateral and forward flexion and extension of the spine. Can detect scoliosis and abnormal
anteropostero curve. It also measures the unstable lumbosacral, cervical and thoracic curves
Miscellaneous
Examination Lamp A well-lit exam room improves visibility and allows patients to be at ease. Intended to be used for examination of YES A well-lit exam
the patient. room improves
visibility and
examination of the patient of the patient in a medical or surgical setting. allows patients to
be at ease.
Intended to be
used for
examination of
the patient in a
medical or
surgical setting.
Mirrors Therapy mirrors are an important aid for rehab therapy and exercise and provide patients with visual feedback. NO
Privacy Screens It is intended for dividing the privacy section of a patient during their treatment. NO
Stools Comfortable seating for therapists and professionals, allows easy access to the patient and equipment. NO
Transfer / Gait belts Gait belts are a back saving device for caregivers. Help to lift and transfer. as well as provide a secure grasp on YES
patients with limited mobility and balance deficiencies.
Pediatric Tools
Pediatric Gait Trainers (Crickets, Walker, Kaye, Crutches, Walkers and gait trainers help children to walk thereby increasing independence, self-esteem and social interaction. YES
Luminator, Safety Roller & Stroller)
Pediatric Mobility Product (Crawler, Crawl Trainer) Designed for children who have difficulty being able to crawl, creep or walk often benefit from equipment that YES
helps them move and explore their environment. It will reinforce weight-bearing, shifting and reaching.
Pediatric Positioning: Seating System (Positioning Seat, Designed for children with mild to severe physical involvement. Seating systems can help position the child on YES Facilitate the
Roll Chair, Positioning System) the floor as well as the table to participate in day to day situations with their peers. Combine with wedges, rolls body posture
or blocks to help position the child comfortably.
Positioning wedges, rolls and blocks provide stability and support for individuals lacking some
degree of body control. Use devices when sitting or laying in prone or supine positions.
Pediatric Positioning: Sensory & Vestibular Stimulation (Plastic Inflatables improve balance, coordination, flexibility, strength and are fun. Used by therapists for vestibular YES
ball stool/trainer, plastic ball chair, wobble ball, inflatable movement and equilibrium therapy, by fitness professionals for stretching and strength programs, as seats, and
exercise balls, saddl rolls, tortoise shell, crawl mat/box, barrel even in birthing classes. Under inflate for a soft, cushy feel or fully inflate for a firm, bouncy feel. Use during
roll) vestibular therapy stimulation, training, general balance exercise, aids in developing muscles, coordination &
balance and grossing motor skillsPediatric Positioning: Swing Frames for Vestibular Training Adaptive swings provide safety and support for children with children with special needs and allow socialization at YES
and Play Therapy, Swing Seat, Swing System the same time It accommodates therapy modules for vestibular, neurodevelopmental, and sensory integration
therapy. Swing seats are ideal for improving vestibular function as well as developing visual, spatial, perception
and postural control abilities.
Reachers
Reachers (Flexible jaw reacher, raptor reacher, open-jaw Help people retrieve hard to reach items by giving an additional length without having to bend, stretch or strain the NO
reacher) body.
Rehabilitation Software
Rehabilitation Software System Provide single-user training, such as balance, muscle endurance, range of motion of extremities. It also allows NO
therapists to adjust difficulty levels to set up different training goals for specific patients
6Appendix 1
DRAFT GUIDANCE DOCUMENT OF REHABILITATION PRODUCTS
PRODUCT NAME DESCRIPTION / PRIMARY INTENDED PURPOSE/ INDICATION MEDICAL REMARKS
DEVICE
Speech Therapy
Cognitive, Speech & Sensory Motor Management (Cognitive To determine baseline function and serial changes in adult clients with cognitive disorder YES
Performance Test)
Cognitive, Speech & Sensory Motor Management Use to obtain a detailed cognitive profile to effectively plan for intervention management and maintenance using YES
(Dexterity Test) the non-injured hand, followed by a timed test of each hand. Quick and simple-to-administer dexterity test.
Cognitive, Speech & Sensory Motor Management (Extension Ideal for active finger extension, for pinching practice, or as a cognitive problem-solving game. NO
Remedial Game)
Cognitive, Speech & Sensory Motor Management Designed for testing loss of protective sensation due to peripheral neuropathy, diabetic foot, nerve compression YES
(Monofilaments SensoryEvaluator) injuries
Cognitive, Speech & Sensory Motor Management A sensory stimulation and basic cognitive rehabilitation program including auditory, visual, olfactory, gustatory and YES
(Sensory Stimulation Activities Kit) tactile stimuli.
Cognitive, Speech & Sensory Motor Management Great for coordination and perceptual training activities. Ideal for upper extremity activities, reaching and grasping, NO
(Stacking Cones) eye-hand corrdination, color identification and perceptual training.
Cognitive, Speech & Sensory Motor Management Use to retest clients and monitor improvement during treatment YES
(Stereognosis Kit)
Cognitive, Speech & Sensory Motor Management Help for persons with arthritis, limited grip, person with diminished finger control. NO As an aid for daily
(Card Holder) living
Cognitive, Speech & Sensory Motor Management (Crochet Designed as a holder for knitting, crocheting, embroidery and darning. NO As an aid for daily
and Embroidery Hoop) living
Cognitive, Speech & Sensory Motor Management Designed by speech therapist for use with neurologically impaired developmentally delayed adults, kids for speech YES
(Speech Remedy Kit) therapy session, cognitive group therapy, caregiver training. Focus on improving cognitive skills. For home and
clinic use.
Cognitive, Speech & Sensory Motor Management (Stringing For improving fine-motor skills, teaching early graphing concepts, develop and strengthen visual perception NO
Peg, Peg Boards) skills, visual motor coordination and fine motor skills
DR Speech Software Real Analysis is a real-time biofeedback tool for use in a clinic and educational environment. By providing a wide NO
range of parameters and special features, it can benefit both clinicians and clients. It has combined the greatest
array of real-time displays such as spectrogram, F0, intensity, vowel tracking, and formant (LPC). Special
features allow the user to model-match a record sample, thus enhancing the client's biofeedback.Language-based Assessment Kit (i) It is a language-based assessment that Speech-Language Therapists (SLTs) use to assess the language NO
abilities of patients in speech therapy clinics. Also to help discern the presence, degree and type of aphasia. It also
measure how the patient performed on the test to provide a baseline, to see the patient’s language strengths and
weakness
(ii) Intended for screening and therapy for children with speech problem.
(iii) The stickers act as a reinforcer for children after they have finished the task given by the therapists, teachers
or parents. Only intended for educational purpose.
(iv) Intended to assess the receptive language (comprehension), expressive language (production ), and early
literacy skills. Also intended to assess the language of children whose language is impaired secondary to autism,
dyslexia, hearing impairment, Down Syndrome, language delay, etc.
Speech Software Games IC Speech Games which applications for children with speech and language disorder. Contains six interactive NO
speech therapy games. Each game features adjustable targets, rewards and can respond to a number of speech
parameters (Speech intensity (loudness), voice intensity (voicing) and Pitch)
Stretching Aids
Ankle Stretching Aids Stability and support for stretching lower leg. Rocker is the ultimate tool for preventing and relieving plantar NO
fasciitis, Achilles tendonitis, tight calves and hamstrings. Can be used while standing or sitting.
Hand Stretcher Lightweight exercisers to stretch, tone and shape. Comfortable material for resistance exercising. NO
Treadmill / Body Trainer / Bike / Eliptical
Body Trainer (Upper & Lower Body Trainer) The purpose of total body ergometer is to restore some or all of the patient’s physical, sensory, and mental YES
capabilities that were lost due to injury, illness, or disease. Total body ergometer is a treatment or treatments
designed to facilitate the process of recovery from injury, illness or disease to as normal a condition as possible.
Exercise Bikes, Elipticals and Treadmills Full suite of treadmills, ellipticals and fitness bikes that are sturdy enough to last years while keeping pace with NO
long-term fitness goals. Upper and lower body exercisers stimulate circulation, muscle strength, joint range-of-
motion and coordination. Exercisers include LCD for measuring work performed. Muscle activation figure shows
which areas are being targeted.
Rehabilitation Treadmill Intended to be used for patients in any stage of rehabilitation with the assistant of physical therapist and nurses. YES
Treadmill Treadmill is a device generally used for walking, running or climbing while staying in the same place (wellness NO
purpose)
Treadmill Treadmill which specifically intended for therapy or cardiac therapy purposes. YES
8Appendix 1
DRAFT GUIDANCE DOCUMENT OF REHABILITATION PRODUCTS
PRODUCT NAME DESCRIPTION / PRIMARY INTENDED PURPOSE/ INDICATION MEDICAL REMARKS
DEVICE
Upper Range-of-Motion (ROM) Exerciser (Finger / Wrist / Hand / Shoulder)
Adjustable Hand Grip Exerciser Use for muscle tendon groups of the hand and forearm. Promotes comfort and versatility. NO
Ergonomic Hand Grip It is intended for strengthening wrists, hands, finger and forearms from earliest stages of rehabilitation and athletic YES
training
Exercise Putty and Putty Tools Can be used in therapy to improve grip strength, dexterity, and hand strengthening through finger, hand and YES
wrist resistive exercises. Each color-coded putty comes in different consistencies ranging from XX-Soft to X-
Firm, for pediatrics to seniors. Enable users to compliment the work done at the clinic or hospital, allowing
strength and mobility progress to continue at home
Finger Weight Exerciser Helps prevent this by isolating both the extensors and flexors, the muscles responsible for opening and closing YES
the fingers. Fingerweights are uniquely designed to be worn during functional, everyday activities. It stays
comfortably and securely on your fingers while being used for general exercise, therapy and rehabilitation.
Promoting speed and finesse in addition to strength. FingerWeights are ideal for athletes, musicians, eSports and
general wellness.
Flexible Hand Bar Exercise Flexible hand bar exerciser is a lightweight, portable exerciser designed to strengthen muscles in the hand, wrist YES
and shoulder. Also promotes coordination and increases range-of-motion.
Perform oscillation movements for neuromuscular and balance training.
Hand Exercise Balls Gel squeeze ball hand exercisers can be used for grip strength, dexterity, mobility, and fine and gross motor skills. YES
Hand Exercise Web Hand therapy exercise web is used in hand therapy for flexion, extension, opposition, and supination exercises YES
Hand Exercise with Band Designed to develop isolated finger strength, flexibility and coordination, therapy device that isolates the extension YES
of all five fingers and each of the individual finger joints. Also builds hand and forearm strength to aid in the
rehabilitation of carpal tunnel, arthritis, stroke, fractures, tendon injuries, nerve lacerations and tennis elbow.
Hand Exercisers (Hand Grip Exerciser, Hand Ball hand exerciser that helps develops isolated finger strength, flexibility, and coordination for rehabilitation of carpel YES
Exerciser) tunnel, arthritis, stroke, fractures, tendon injury, nerve lacerations, tennis elbow and more.
Pedal Exerciser Pedal exercisers are portable exercisers for both the upper and lower body. Can be used on the floor for foot NO
pedaling, or on the tabletop for hand pedaling. Perfect for clinic or in-house use, portable upper and lower body
exercisers stimulate circulation, muscle strength, joint range-of-motion and coordination
Pinch Finger Exerciser Improve hand and finger strength and coordination with the CanDo Graded Pinch Exerciser. Utilized by patients YES
recovering from hand injuries or individuals with disabilities. They are ideal for a variety of applications, including
sports facilities, physical therapy centers, clinics, hospitals, and retirement homes.
Power Wheel System (Hand wheel, Shoulder wheel, Enable the repetitive practice of different movement and task including fingers. To improve hand, shoulder and YES
Wrist Wheel) elbow's range-of-motion and strengthen specific hand / shoulder / arm muscle. For rehabilitation purposes.
Range-of-Motion (ROM) Exercise (Jux-a- Cisor™) Range-of-Motion exerciser for finger, hand, wrist, elbow, and shoulder NO
Rubber Band Hand Exerciser It is intended for hand and finger flexion exercises NOShoulder Exerciser with Adjustable Wall Mounted Bracket Shoulder Exerciser with an Adjustable Wall Mounted Bracket is an upper body pedal exerciser ideal for increasing NO
muscle strength, improving range-of-motion, developing coordination and enhancing circulation.
Shoulder Pulley Simple and effective shoulder therapy aids increase range of motion in the shoulder. Used to increase shoulder NO
range of motion. Allows one shoulder to compensate for the other post- surgery.
Shoulder/Finger Ladder (wooden stall bar) Wall-mounted finger and shoulder ladder offers progressive mobility of arm at shoulder, elbow and wrist joints. NO
providing benefits to the beginner athlete as well as fitness professionals and athletes. Perfect for and found in
sports medicine clinics, gyms, physical therapy offices and hospitals. To improve flexibility, strength and mobility,
users can exercise from a sitting or standing position.
Upper Body Range-of-Motion (ROM) Exercises (Double Increase upper extremity ROM, strength, coordination and endurance, or improve cognitive and visual skills. For YES
Curved Shoulder Arc, Climbing Board, Horizontal Ring Tree, people with neurological disorders, burns and orthopedic problems
Incline Board, Vertical Ring Tree,Semi- Circular Pegboard,
Pipe Tree)
Upper Trainer It can change from lower to upper trainer with a somple twist/turn knob. The kit enables both upper or lower active- NO
passive training in one device.
Wrist Flexion and Extension Exercise Intended for exercise for fingers, hand, wrist, elbow and shoulder NO
10Appendix 1
DRAFT GUIDANCE DOCUMENT OF REHABILITATION PRODUCTS
PRODUCT NAME DESCRIPTION / PRIMARY INTENDED PURPOSE/ INDICATION MEDICAL REMARK
DEVICE S
Wedges / Rolls / Balls / Disc
Ball Chair The mobile ergonomic seating systems combine the benefits of ball therapy with the convenience of a chair base. NO
Inflatables improve balance, coordination, flexibility, strength and are fun. Used by therapists for vestibular
movement and equilibrium therapy, by fitness professionals for stretching and strength programs, as seats, and
even in birthing classes.
Bed Wedges Help restore and maintain correct posture. The gentle incline helps promote proper posture while performing daily NO
tasks.
Exercise Positioning (Wedges, rolls, half rolls, knee support) Wedges are made of molded foam coated with a tough integral washable coating. Heavy duty positioning and YES
vestibular wedges are ideal for institutional use in physical therapy departments, home use, special education
programs, pre-school programs, physical education classes and the gym. They can be used under the back, arm,
or leg of a patient for comfortable and functional positioning. They can be used to provide the necessary leverage
to promote an exercise regime.
Rolls are made of molded foam coated with an integral washable coating. Heavy duty positioning and vestibular
rolls are ideal for institutional use in physical therapy departments, home use, special education programs, pre-
school programs, physical education classes and the gym. The Skillbuilders roll has an attached handle for
hanging and carrying.
Foam Ball Exerciser Intended for the early stages of hand rehabilitation. YES
Foam Roller Used for all therapeutic exercises including; physical therapy, training, conditioning, core strength, stability NO
stretching, postural alignment and balance. Rollers also enhance massage sessions
Inflatable Balance Discs, Sitting and Standing Balance Disc Inflatable vestibular disc mimics the movement and shape of an Inflatable ball when used on any seat. Use it on NO
the floor as a standing disc for balance training, proprioception and strengthening of the lower extremities. For
tactile feedback and stimulation, and one flat side.
Inflatable Balance Wedges Inflatable wedge requires active participation from user to assume correct sitting posture. NO
Inflatable Exercise Balls / Saddle Rolls Inflatables improve balance, coordination, flexibility, strength and are fun. Used by therapists for vestibular NO
movement and equilibrium therapy, by fitness professionals for stretching and strength programs, as seats, and
even in birthing classes.
Massage Balls and Rollers The “bumpy” textured surface promotes sensory stimulation and is perfect for manual dexterity exercises. The rollers NO
are effective for feet and large areas.The massage balls and rollers help achieve muscle and tension release for all
parts of the body
WeightsDumbbells and Kettlebells Dumbbells are comfortable to grip and does not allow the dumbbells to scratch the flooring. They are ideal to use NO
for upper body exercises, physical therapy, weight training and toning workouts.
Kettlebells are ideal for strength training and toning. Each kettlebell has vibrant colors making
it easy to identify weights. The coating on the weights reduces the potential for floor scratching.
Hand-Held Weights Hand held weight ball offers all the benefits of traditional weight training without using hard-to- hold metal NO
dumbbells. Pliable exterior makes for easy grasping and textured surface makes it slip-free. Use for strengthening,
plyometrics, balance training, mobilization and functional grip strength development.
Wrist and Ankle weights, Adjustable Cuff Weight Wrist or ankle weight has snug fit and padded interior for comfortable fit. The weight ships withweight inserts pre- NO
inserted into the weight pockets. Use for progressive therapy or exercise, helps increase strength and toning in
arms, wrists, shoulders and ankles.
2MEDICAL DEVICE AUTHORITY
MINISTRY OF HEALTH, MALAYSIA
Contact Information:
Medical Device Authority
Ministry of Health Malaysia
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor,
MALAYSIA
T: (03) 8230 0300
F: (03) 8230 0200
Website: http://www.mda.gov.my
1You can also read
