Disabled/Handicapped Hygiene Adaptor Suppliers
Limit companies to: Worldwide USA
Maddak, Inc. | Address: 661 Route 23 South, Wayne, New Jersey 07470, USA 
www.maddak.com | Send Inquiry | Phone: +1-(973)-628-7600
Year Established: 1971 Annual Revenues: USD 25-50 Million Employee Count: ~10 Quality: ISO 9000 Certified
Products: Walkers, Bath Accessories, Chairs & stools, Crutches, Canes, Walkers, General Medical Supplies, General Orthopedic Supplies, ...
Maddak, Inc designs and produces assistive devices. We provide clinical modality assessment and evaluation tools for the professional therapist. Our Pediatrics Children's Chaise™ consist of a se more...
www.maddak.com | Send Inquiry | Phone: +1-(973)-628-7600
Year Established: 1971 Annual Revenues: USD 25-50 Million Employee Count: ~10 Quality: ISO 9000 Certified
Products: Walkers, Bath Accessories, Chairs & stools, Crutches, Canes, Walkers, General Medical Supplies, General Orthopedic Supplies, ...
Maddak, Inc designs and produces assistive devices. We provide clinical modality assessment and evaluation tools for the professional therapist. Our Pediatrics Children's Chaise™ consist of a se more...
Tumble Forms, Inc. | Address: 1013 Barker Rd., Dolgeville, New York 11329, USA
Phone: +1-(262)-387-8720
FDA Registration: 2435707
Products: Wheelchair Accessories (FDA Code: KNO), Medical Chair and Table (FDA Code: KMN), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Table (FDA Code: INW), Non-Measuring Exerciser (FDA Code: ION), ...
Tumble Forms, Inc. specializes in offering wheelchair accessories, medical chair and table, mechanical table. We also provide prone scooter board and disabled adaptors. more...
Phone: +1-(262)-387-8720
FDA Registration: 2435707
Products: Wheelchair Accessories (FDA Code: KNO), Medical Chair and Table (FDA Code: KMN), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Table (FDA Code: INW), Non-Measuring Exerciser (FDA Code: ION), ...
Tumble Forms, Inc. specializes in offering wheelchair accessories, medical chair and table, mechanical table. We also provide prone scooter board and disabled adaptors. more...
F.M. Howell & Co. | Address: 151 East Fifth St., P.O. Box 286, Elmira, New York 14902, USA
www.howellpkg.com | Send Inquiry | Phone: +1-(607)-734-6291
FDA Registration: 1313700
Products: Blood Collection Lancet (FDA Code: FMK), Glucose Glucose Dehydrogenase (FDA Code: LFR), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Contract Packaging, Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
F.M. Howell & Company designs and manufactures folding cartons & rigid paperboard boxes. We provide thermoformed plastic packaging, carded packaging, and barrier packaging products, as well as custom more...
www.howellpkg.com | Send Inquiry | Phone: +1-(607)-734-6291
FDA Registration: 1313700
Products: Blood Collection Lancet (FDA Code: FMK), Glucose Glucose Dehydrogenase (FDA Code: LFR), Over-The-Counter Blood Glucose Test System (FDA Code: NBW), Contract Packaging, Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
F.M. Howell & Company designs and manufactures folding cartons & rigid paperboard boxes. We provide thermoformed plastic packaging, carded packaging, and barrier packaging products, as well as custom more...
Gale Product Group, Llc | Address: 1350 Buffalo Rd, Suite 15, Rochester, New York 14624, USA
Phone: +1-(585)-225-7010
Products: Bed Transfer Aids, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Gale Product Group, Llc offers medical products for disabled and handicapped. Our product line comprises of disabled & handicapped hygiene adaptors, transfer aids, mechanical adjustable chairs, mechan more...
Phone: +1-(585)-225-7010
Products: Bed Transfer Aids, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Gale Product Group, Llc offers medical products for disabled and handicapped. Our product line comprises of disabled & handicapped hygiene adaptors, transfer aids, mechanical adjustable chairs, mechan more...
Kaye Products, Inc. | Address: 535 Dimmocks Mill Rd., Hillsborough, North Carolina 27278-2352, USA
www.kayeproducts.com | Send Inquiry | Phone: +1-(919)-732-6444
FDA Registration: 1047834 Quality: ISO, CE Certified
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Patient Position Support (FDA Code: CCX), Infant Position Holder (FDA Code: FRP), Pediatric Chair, Walker Accessories, ...
Kaye Products, Inc. manufactures and sells mobility aids, adaptive positioning equipment & therapy products for infants, children & young adults with special needs. We specialize in PostureRest walker more...
www.kayeproducts.com | Send Inquiry | Phone: +1-(919)-732-6444
FDA Registration: 1047834 Quality: ISO, CE Certified
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Patient Position Support (FDA Code: CCX), Infant Position Holder (FDA Code: FRP), Pediatric Chair, Walker Accessories, ...
Kaye Products, Inc. manufactures and sells mobility aids, adaptive positioning equipment & therapy products for infants, children & young adults with special needs. We specialize in PostureRest walker more...
Health Care Logistics | Address: PO Box 25, Circleville, Ohio 43113-0025, USA
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Capillary Blood Collection Tubes (FDA Code: GIO), Urine Collection Leg Bags (FDA Code: FAQ), Cabinets, IV Catheters & Infusion Sets, ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
www.hcl-intl.com | Send Inquiry | Phone: +1-(800)-848-1633
FDA Registration: 1530671 Year Established: 1978 Employee Count: ~120
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Capillary Blood Collection Tubes (FDA Code: GIO), Urine Collection Leg Bags (FDA Code: FAQ), Cabinets, IV Catheters & Infusion Sets, ...
Health Care Logistics supplies emergency products, pharmacy products, infection control products, key cabinets & tablet crushers. Our extensive line of daily aids include ideas such as medication orga more...
Dalton Instrument Corporation | Address: 3788 Arapaho Road, Addison, Texas 75001, USA
www.daltoninstrument.com | Send Inquiry | Phone: +1-(469)-522-1200
Products: Oxygen Masks (FDA Code: BYG), Patient Lifters (FDA Code: FNG), Clamps, Forceps (FDA Code: HTD), Urinary Leg Bags, Nebulizers, ...
Dalton Instrument Corporation specializes in providing products to the medical care industry. Our product line includes categories in durable medical equipments & disposable medical devices such as ho more...
www.daltoninstrument.com | Send Inquiry | Phone: +1-(469)-522-1200
Products: Oxygen Masks (FDA Code: BYG), Patient Lifters (FDA Code: FNG), Clamps, Forceps (FDA Code: HTD), Urinary Leg Bags, Nebulizers, ...
Dalton Instrument Corporation specializes in providing products to the medical care industry. Our product line includes categories in durable medical equipments & disposable medical devices such as ho more...
Adaptive Switch Laboratories, Inc. | Address: 125 Spur 191, Suite C, Spicewood, Texas 78669, USA
www.asl-inc.com | Send Inquiry | Phone: +1-(830)-7980005
FDA Registration: 1645143
Products: Headrest System, Adapters & Connectors, Sensor Tee Adapter, Control Switches, Wheelchair Ramp for Disabled/Handicapped, Handicapped Living Aid, Handicapped Vehicle, ...
Adaptive Switch Laboratories, Inc. manufactures adaptive wheelchair components. We offer proximity head array package. This driver control is typically used with individuals with developmental disabil more...
www.asl-inc.com | Send Inquiry | Phone: +1-(830)-7980005
FDA Registration: 1645143
Products: Headrest System, Adapters & Connectors, Sensor Tee Adapter, Control Switches, Wheelchair Ramp for Disabled/Handicapped, Handicapped Living Aid, Handicapped Vehicle, ...
Adaptive Switch Laboratories, Inc. manufactures adaptive wheelchair components. We offer proximity head array package. This driver control is typically used with individuals with developmental disabil more...
James Leckey Design Ltd | Address: Kilwee Business Park, Dunmurry, Belfast BT170HD, United Kingdom 
www.leckey.com | Send Inquiry | Phone: +44-(28)-90602277
FDA Registration: 9681189
Products: Bathroom Accessories, Bath Seats, Toilet Aids, Raised Toilet Seat with Arms, Positioning Systems, Head Supports, Pediatric Standing Systems, Therapy Equipment, Therapeutic Sleeping Pillow, ...
James Leckey Design Ltd specializes in the production of early sitting systems, early activity systems, sleeping and lying products, mobility products, bath& toilet seats, therapy equipments and head more...
www.leckey.com | Send Inquiry | Phone: +44-(28)-90602277
FDA Registration: 9681189
Products: Bathroom Accessories, Bath Seats, Toilet Aids, Raised Toilet Seat with Arms, Positioning Systems, Head Supports, Pediatric Standing Systems, Therapy Equipment, Therapeutic Sleeping Pillow, ...
James Leckey Design Ltd specializes in the production of early sitting systems, early activity systems, sleeping and lying products, mobility products, bath& toilet seats, therapy equipments and head more...
DLP Limited DBA AKW Medicare | Address: Unit L, Snugborough, Braddan, Isle Of Man IM4 4LH, United Kingdom
Phone: +44-(1624)-691620
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Adjustable Chair (FDA Code: INN), ...
DLP Limited DBA AKW Medicare provides hygiene adapters, mechanical adjustable chairs, and transfer aids for disabled/handicapped patients. more...
Phone: +44-(1624)-691620
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Adjustable Chair (FDA Code: INN), ...
DLP Limited DBA AKW Medicare provides hygiene adapters, mechanical adjustable chairs, and transfer aids for disabled/handicapped patients. more...
Nottingham Rehab Supplies | Address: Clinitron House, Excelsior Rd., Ashby Park, Ashby De La Zouch, Leicestershire LE65 1JG, United Kingdom
www.nrs-uk.co.uk | Send Inquiry | Phone: +44-(0845)-1204522
Products: Medical Monitors, Exercise Mats, Wheelchairs, Exercise Therapy Equipment, Bathroom Accessories, Bath Seats, Ramp, ...
Nottingham Rehab Supplies specializes in the production of daily living aid products. Our product line comprises of pill reminder, infection control, toileting seats & accessories, emergency evacuatio more...
www.nrs-uk.co.uk | Send Inquiry | Phone: +44-(0845)-1204522
Products: Medical Monitors, Exercise Mats, Wheelchairs, Exercise Therapy Equipment, Bathroom Accessories, Bath Seats, Ramp, ...
Nottingham Rehab Supplies specializes in the production of daily living aid products. Our product line comprises of pill reminder, infection control, toileting seats & accessories, emergency evacuatio more...
Bollya International Co., Ltd. | Address: 2f., No.157, Guang Fu Street, Banciao City Taipei County 22068, Taiwan 
Phone: +886-(2)-22137758
Products: Patient Lifters (FDA Code: FNG), Walkers, Medical Accessories, Blades/Handles, Hydraulic Patient Lifter, Wheelchair Accessories (FDA Code: KNO), Shower Chair Commodes, ...
Bollya International Co., Ltd. manufactures wheelchair, rollator and hospital bed. We offer commode chair, shower bench, hospital equipment, walker, canes, medical accessories and lifter. more...
Phone: +886-(2)-22137758
Products: Patient Lifters (FDA Code: FNG), Walkers, Medical Accessories, Blades/Handles, Hydraulic Patient Lifter, Wheelchair Accessories (FDA Code: KNO), Shower Chair Commodes, ...
Bollya International Co., Ltd. manufactures wheelchair, rollator and hospital bed. We offer commode chair, shower bench, hospital equipment, walker, canes, medical accessories and lifter. more...
Medcare Manufacturing Inc. | Address: No.351, Chungcheng Road, Sec. 2, Changhua 500, Taiwan
www.medcare.com.tw | Send Inquiry | Phone: +886-(4)-7249349
Quality: ISO 13485 Certified
Products: Wheelchair Accessories (FDA Code: KNO), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Air Flotation Mattress (FDA Code: FNM), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Medcare Manufacturing Inc. provides wheelchairs, quad canes, walkers and I.V. poles. Our walkers are available in two types such as basic type and R type. We also provide power wheelchairs, commode ch more...
www.medcare.com.tw | Send Inquiry | Phone: +886-(4)-7249349
Quality: ISO 13485 Certified
Products: Wheelchair Accessories (FDA Code: KNO), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Air Flotation Mattress (FDA Code: FNM), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Medcare Manufacturing Inc. provides wheelchairs, quad canes, walkers and I.V. poles. Our walkers are available in two types such as basic type and R type. We also provide power wheelchairs, commode ch more...
Ibox Corporation | Address: 10, Lane 630, Sec.1, Daya Road, Chiayi 60076, Taiwan
Phone: +886-(5)-2788613
Products: Manual Beds (FDA Code: FNJ), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Table (FDA Code: INW), Mechanical Walker (FDA Code: ITJ), ...
Ibox Corporation is a manufacturer of medical equipments such as manual beds, handicapped canes, mechanical walkers and infusion stands. more...
Phone: +886-(5)-2788613
Products: Manual Beds (FDA Code: FNJ), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Table (FDA Code: INW), Mechanical Walker (FDA Code: ITJ), ...
Ibox Corporation is a manufacturer of medical equipments such as manual beds, handicapped canes, mechanical walkers and infusion stands. more...
Maxhealth Corporation | Address: 15F-6, No. 81, Hsin Tai Wu Rd., Sec. 1, Hsi Chih, Taipei Hsien, Taiwan
www.maxhealth.com.tw | Send Inquiry | Phone: +886-(2)-26984169, 26982487
FDA Registration: 9615543
Products: Patient Lifters (FDA Code: FNG), Wheelchair Accessories (FDA Code: KNO), Ac-Powered Patient Lifts (FDA Code: FNG), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Patient Lifts and Accessories (FDA Code: FNG), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), ...
Maxhealth Corporation offers wheelchairs, rollators, crutches, walkers and bathroom safety facilities. We are also capable of providing OEM and ODM products. We offer various walkers including rehab, more...
www.maxhealth.com.tw | Send Inquiry | Phone: +886-(2)-26984169, 26982487
FDA Registration: 9615543
Products: Patient Lifters (FDA Code: FNG), Wheelchair Accessories (FDA Code: KNO), Ac-Powered Patient Lifts (FDA Code: FNG), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Patient Lifts and Accessories (FDA Code: FNG), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), ...
Maxhealth Corporation offers wheelchairs, rollators, crutches, walkers and bathroom safety facilities. We are also capable of providing OEM and ODM products. We offer various walkers including rehab, more...
Homecare Enterprise Co., Ltd. | Address: No. 11, Changsheng Street, Huatan, Changhua 50347, Taiwan
www.homecare.tw | Send Inquiry | Phone: +886-(4)-788-2451
FDA Registration: 3005214422 Quality: ISO 9001:2000 Certified
Products: Walkers, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN), Bedrail, ...
Homecare Enterprise Co.,Ltd. focuses on the production of medical equipments. Our products comprise of canes and crutches, bath safety products, respiratory and patient room products. Our respiratory more...
www.homecare.tw | Send Inquiry | Phone: +886-(4)-788-2451
FDA Registration: 3005214422 Quality: ISO 9001:2000 Certified
Products: Walkers, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN), Bedrail, ...
Homecare Enterprise Co.,Ltd. focuses on the production of medical equipments. Our products comprise of canes and crutches, bath safety products, respiratory and patient room products. Our respiratory more...
Elitex Metal Group Mfg. Corp. | Address: 20, Gungye 3rd Rd., Min Hsiung Shiang, Chaiyi, Taiwan
www.elitex.com.tw | Send Inquiry | Phone: +886-(720)-9625412
Products: Patient Lifters (FDA Code: FNG), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Chairs, Ac-Powered Patient Lifts (FDA Code: FNG), Patient Lifts and Accessories (FDA Code: FNG), ...
Elitex Metal Group Mfg. Corp deals with health care products. Our products include patient lifts, hospital furniture, hospital equipment, home care products and rehabilitation products. This patient l more...
www.elitex.com.tw | Send Inquiry | Phone: +886-(720)-9625412
Products: Patient Lifters (FDA Code: FNG), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Chairs, Ac-Powered Patient Lifts (FDA Code: FNG), Patient Lifts and Accessories (FDA Code: FNG), ...
Elitex Metal Group Mfg. Corp deals with health care products. Our products include patient lifts, hospital furniture, hospital equipment, home care products and rehabilitation products. This patient l more...
Apex Health Care Mfg., Inc. | Address: No. 20 Industrial 3rd Rd.,Tou, Chiao Industrial Park, Min Hsiung, Chia Yi, Taiwan
www.apexcare.com.tw | Send Inquiry | Phone: +886-(5)-2133889
FDA Registration: 3003094481
Products: Patient Lifters (FDA Code: FNG), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Ac-Powered Patient Lifts (FDA Code: FNG), Patient Lifts and Accessories (FDA Code: FNG), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Apex Health Care Mfg., Inc. is a manufacturer and designer of health care products. Our products include patient lifts, hospital furniture, hospital equipment, and home care products. APC-10170E delux more...
www.apexcare.com.tw | Send Inquiry | Phone: +886-(5)-2133889
FDA Registration: 3003094481
Products: Patient Lifters (FDA Code: FNG), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Ac-Powered Patient Lifts (FDA Code: FNG), Patient Lifts and Accessories (FDA Code: FNG), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Apex Health Care Mfg., Inc. is a manufacturer and designer of health care products. Our products include patient lifts, hospital furniture, hospital equipment, and home care products. APC-10170E delux more...
Link Treasure Limited Taiwan Branch | Address: No.22, Kuang-Fu Road, Chia-Tai Industrial, Tai Pao City, Chia Yi Hsien 61252, Taiwan
Phone: +886-(3)-5208829
Products: Patient Lifters (FDA Code: FNG), Wheelchair Accessories (FDA Code: KNO), Ac-Powered Patient Lifts (FDA Code: FNG), Feeding Needles (FDA Code: FNN), Patient Lifts and Accessories (FDA Code: FNG), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), ...
Link Treasure Limited Taiwan Branch offers AC-powered patient lifts, disabled and handicapped manual wheelchairs, disabled and handicapped motorized 3-wheeled vehicles & disabled and handicapped hygie more...
Phone: +886-(3)-5208829
Products: Patient Lifters (FDA Code: FNG), Wheelchair Accessories (FDA Code: KNO), Ac-Powered Patient Lifts (FDA Code: FNG), Feeding Needles (FDA Code: FNN), Patient Lifts and Accessories (FDA Code: FNG), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), ...
Link Treasure Limited Taiwan Branch offers AC-powered patient lifts, disabled and handicapped manual wheelchairs, disabled and handicapped motorized 3-wheeled vehicles & disabled and handicapped hygie more...
Merits Health Products, Inc. | Address: 9, Rd 36, Taichung Industrial Park, Taichung 40768, Taiwan
www.merits.com.tw | Phone: +886-(4)-2359-4991
FDA Registration: 9680333
Products: Wheelchair Accessories (FDA Code: KNO), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Direct Patient Interface Nebulizer (FDA Code: CAF), ...
Merits Health Products, Inc. is a provider of home medical equipments for disabled and aged people. Our products include electric scooters, power chairs, respiratory products, wheelchairs, patient aid more...
www.merits.com.tw | Phone: +886-(4)-2359-4991
FDA Registration: 9680333
Products: Wheelchair Accessories (FDA Code: KNO), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Direct Patient Interface Nebulizer (FDA Code: CAF), ...
Merits Health Products, Inc. is a provider of home medical equipments for disabled and aged people. Our products include electric scooters, power chairs, respiratory products, wheelchairs, patient aid more...
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FDA Code / Regulation: ILS / 890.5050
A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, regarding general requirements concerning records and 820.198, regarding complaint files.
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