Disabled/Handicapped Hygiene Adaptor Suppliers
Limit companies to: Worldwide USA
Zhongshan Rexon Rehabilitation Equipment Company L | Address: No.23,Tai Yu Road, Xiaolan, Industry Zone, Xiaolan Town, Zhongshan City,Guangdong Provi, China 
FDA Registration: 3004078013
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Manual Patient Transfer Device (FDA Code: FMR), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Zhongshan Rexon Rehabilitation Equipment Company L deals with medical equipments such as handicapped canes, mechanical walkers, and manual patient transfer devices. We also offer mechanical adjustable more...
FDA Registration: 3004078013
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Manual Patient Transfer Device (FDA Code: FMR), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Zhongshan Rexon Rehabilitation Equipment Company L deals with medical equipments such as handicapped canes, mechanical walkers, and manual patient transfer devices. We also offer mechanical adjustable more...
H&k International Trade Limited (china) | Address: 15th Floor, Tower B, International Plaza, 518, Shuanglong South Road, Jinhua, CN-33 321017, China
www.hnk-intl.com | Send Inquiry | Phone: +86-(579)-82131800
FDA Registration: 3008386507
Products: Bathroom Chairs, Bath Chair, Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
H&k International Trade Limited (china) specializes in medical products and hand tools. We also offer bath chairs, rollators and fitness equipments. more...
www.hnk-intl.com | Send Inquiry | Phone: +86-(579)-82131800
FDA Registration: 3008386507
Products: Bathroom Chairs, Bath Chair, Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
H&k International Trade Limited (china) specializes in medical products and hand tools. We also offer bath chairs, rollators and fitness equipments. more...
Eewell Homecare Products Co., Ltd. | Address: Qinghu East Road, Qinghu Industrial Park, Yuliangwei Management Area, Qingxi Town, Dongguan City, CN-44 523649, China
eewell.com | Send Inquiry | Phone: +86-(769)-873-00001
FDA Registration: 3008197931
Products: Wheelchair Footrests (FDA Code: IMM), Empty Gas Cylinder (FDA Code: KGA), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Safety Walk Cane (FDA Code: KHY), Wheelchair Commode Attachment (FDA Code: INB), ...
Eewell Homecare Products Co., Ltd. manufactures home healthcare products. We provide wheelchairs, rollators, walkers, patient lifters, overbed tables, IV poles and bedrails. We offer aluminum transfer more...
eewell.com | Send Inquiry | Phone: +86-(769)-873-00001
FDA Registration: 3008197931
Products: Wheelchair Footrests (FDA Code: IMM), Empty Gas Cylinder (FDA Code: KGA), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Safety Walk Cane (FDA Code: KHY), Wheelchair Commode Attachment (FDA Code: INB), ...
Eewell Homecare Products Co., Ltd. manufactures home healthcare products. We provide wheelchairs, rollators, walkers, patient lifters, overbed tables, IV poles and bedrails. We offer aluminum transfer more...
Foshan Suncare Medical Products Co Ltd | Address: No.12,Dongcheng Rd,Fuwan, Industry Area, Gaoming District, Foshan, CN-44 528500, China
www.suncare-medical.com | Send Inquiry | Phone: +86-(757)-88211269
FDA Registration: 3008386649
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Foshan Suncare Medical Products Co Ltd. is a manufacturer of durable medical equipments(DME) and hospital furniture. Our product line include wheel chair, mobility scooter, walking aids, bathroom safe more...
www.suncare-medical.com | Send Inquiry | Phone: +86-(757)-88211269
FDA Registration: 3008386649
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Foshan Suncare Medical Products Co Ltd. is a manufacturer of durable medical equipments(DME) and hospital furniture. Our product line include wheel chair, mobility scooter, walking aids, bathroom safe more...
Reborn Medical Co., Ltd. | Address: Guangfeng Wei,Yumin Village,, Dongsheng County, Zhongshan City, Guangdong Province, CN-44 528414, China
FDA Registration: 3005783092
Products: Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Safety Walk Cane (FDA Code: KHY), ...
Reborn Medical Co., Ltd. specializes in offering medical equipment, folding walkers and commode chair series. more...
FDA Registration: 3005783092
Products: Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Safety Walk Cane (FDA Code: KHY), ...
Reborn Medical Co., Ltd. specializes in offering medical equipment, folding walkers and commode chair series. more...
Zhongshan Juncheng Hardware Co., Ltd. | Address: 69 Zhaoyi Rd., Dongsheng Town, Zhongshan City, CN-44 528414, China
FDA Registration: 3004859140
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Zhongshan Juncheng Hardware Co., Ltd. manufactures medical recovery instruments. We offer bath stools, telescope crutches, walking sticks and canes. more...
FDA Registration: 3004859140
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Zhongshan Juncheng Hardware Co., Ltd. manufactures medical recovery instruments. We offer bath stools, telescope crutches, walking sticks and canes. more...
Combo (Zhong Shan) Medical Equipment Co., Ltd. | Address: The Rearward Of Building No.83,Yumin Rd., Dongsheng Town, Zhongshan City, CN-44 528414, China
www.combo-china.com | Send Inquiry | Phone: +86-(760)-22220052
FDA Registration: 3007222468
Products: Overbed Table (Furniture, Bedside), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Table (FDA Code: INW), Mechanical Walker (FDA Code: ITJ), Chair with Casters (FDA Code: INM), ...
Combo (Zhong Shan) Medical Equipment Co., Ltd. is a provider of medical equipment. Our product line includes over-bed table, infusion stand, cane, pedal exerciser, wheel chair, shower chair, rollator more...
www.combo-china.com | Send Inquiry | Phone: +86-(760)-22220052
FDA Registration: 3007222468
Products: Overbed Table (Furniture, Bedside), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Table (FDA Code: INW), Mechanical Walker (FDA Code: ITJ), Chair with Casters (FDA Code: INM), ...
Combo (Zhong Shan) Medical Equipment Co., Ltd. is a provider of medical equipment. Our product line includes over-bed table, infusion stand, cane, pedal exerciser, wheel chair, shower chair, rollator more...
Jan Mao Industries Ltd. | Address: Gong Ting Village,First Industrial District,Long Xi Town Bo Luo Hsing, Hui Zhou, Gong Dong 84045, China
www.janmao.com | Send Inquiry | Phone: +886-(2)-2930-0381
Quality: ISO 9001:2000,ISO 9001:2006,ISO9002:94 Certified
Products: Wheelchair Accessories (FDA Code: KNO), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Mechanical Walker (FDA Code: ITJ), Wheelchair Component (FDA Code: KNN), ...
Jan Mao Industries Ltd. specializes in providing aluminum alloy products for health care industry. Our product line includes crutches, canes, patient room products, walkers, walker wheel attachments, more...
www.janmao.com | Send Inquiry | Phone: +886-(2)-2930-0381
Quality: ISO 9001:2000,ISO 9001:2006,ISO9002:94 Certified
Products: Wheelchair Accessories (FDA Code: KNO), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Mechanical Walker (FDA Code: ITJ), Wheelchair Component (FDA Code: KNN), ...
Jan Mao Industries Ltd. specializes in providing aluminum alloy products for health care industry. Our product line includes crutches, canes, patient room products, walkers, walker wheel attachments, more...
Sun Zing Plastic Ironware Co., Ltd. | Address: Songgang District, Qingxi Town, Dongguan, Guang Dong 523660, China
Phone: +866-(2)-23462319
Products: Wheelchair Accessories (FDA Code: KNO), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Wheelchair Commode Attachment (FDA Code: INB), Wheelchair Overhead Suspension Sling (FDA Code: INE), ...
Sun Zing Plastic Ironware Co., Ltd. is engaged in the business of bed rails, rollators, rolling walkers and bath rails. more...
Phone: +866-(2)-23462319
Products: Wheelchair Accessories (FDA Code: KNO), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Wheelchair Commode Attachment (FDA Code: INB), Wheelchair Overhead Suspension Sling (FDA Code: INE), ...
Sun Zing Plastic Ironware Co., Ltd. is engaged in the business of bed rails, rollators, rolling walkers and bath rails. more...
Weijee Metal Products Co., Ltd | Address: No. 17 Tianxin Management Area, Tangxia Town, Dongguan, Guang Dong 523718, China
Phone: +86-(757)-2240177
Products: Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Safety Walk Cane (FDA Code: KHY), ...
Weijee Metal Products Co., Ltd deals with crutches, disabled and handicapped hygiene adaptors and safety walk canes. more...
Phone: +86-(757)-2240177
Products: Crutch (FDA Code: IPR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Safety Walk Cane (FDA Code: KHY), ...
Weijee Metal Products Co., Ltd deals with crutches, disabled and handicapped hygiene adaptors and safety walk canes. more...
Ralon Medical Equipment Co., Ltd. | Address: Xilian Development Zone, Jinsha, Danzao Town, Foshan, Guang Dong 528222, China
www.ralon-medical.com | Send Inquiry | Phone: +86-(757)-86615283
FDA Registration: 3007697870
Products: Wheelchairs, Bathroom Chairs, Manual Beds (FDA Code: FNJ), Commode, Crutch (FDA Code: IPR), Chair with Casters (FDA Code: INM), ...
Ralon medical equipment Co.,Ltd. specializes in the production of medical equipment products including wheelchair, commodes, bathroom chairs, rollators, walkers, canes and underarm crutches. more...
www.ralon-medical.com | Send Inquiry | Phone: +86-(757)-86615283
FDA Registration: 3007697870
Products: Wheelchairs, Bathroom Chairs, Manual Beds (FDA Code: FNJ), Commode, Crutch (FDA Code: IPR), Chair with Casters (FDA Code: INM), ...
Ralon medical equipment Co.,Ltd. specializes in the production of medical equipment products including wheelchair, commodes, bathroom chairs, rollators, walkers, canes and underarm crutches. more...
Genteel Homecare Products Co., Ltd. | Address: Liyu Industry Area, Danzao, Nanhai, Foshan, Guang Dong 528216, China
www.genteelmed.com | Send Inquiry | Phone: +86-(757)-854-44868
FDA Registration: 3010867794
Products: Bathroom accessories, Rollators, Bathroom Chairs, Bariatric Beds & Accessories, Crutch (FDA Code: IPR), Mechanical Walker (FDA Code: ITJ), ...
Genteel Homecare Products Co., Ltd. is engaged in the production of home care products and medical rehabilitation equipment. Our products include homecare products, lifts, wheelchairs, rollators, walk more...
www.genteelmed.com | Send Inquiry | Phone: +86-(757)-854-44868
FDA Registration: 3010867794
Products: Bathroom accessories, Rollators, Bathroom Chairs, Bariatric Beds & Accessories, Crutch (FDA Code: IPR), Mechanical Walker (FDA Code: ITJ), ...
Genteel Homecare Products Co., Ltd. is engaged in the production of home care products and medical rehabilitation equipment. Our products include homecare products, lifts, wheelchairs, rollators, walk more...
Foshan City Nanhai Kaiyang Medical Equipment Co., Ltd | Address: Dali Yanfeng Industrial Park, Foshan, Guang Dong 528231, China
Phone: +086-(757)-85502505
FDA Registration: 3007120364
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Walker (FDA Code: ITJ), ...
Foshan City Nanhai Kaiyang Medical Equipment Co., Ltd deals with disabled/handicapped manual wheelchairs, mechanical adjustable chairs, mechanical walkers and mechanical wheelchairs. more...
Phone: +086-(757)-85502505
FDA Registration: 3007120364
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Walker (FDA Code: ITJ), ...
Foshan City Nanhai Kaiyang Medical Equipment Co., Ltd deals with disabled/handicapped manual wheelchairs, mechanical adjustable chairs, mechanical walkers and mechanical wheelchairs. more...
Foshan Dongfang Medical Equipment Manufactory(ltd) | Address: No.5 Xingfu Rd., Nanhai Shisan Industrial Park, Foshan, Guang Dong 528225, China
Phone: +86-(757)-8120-2180
FDA Registration: 3004194020
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Handicapped Cane (FDA Code: IPS), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Foshan Dongfang Medical Equipment Manufactory (ltd) manufactures products for disabled and handicapped peoples. We offer crutches, crutch and walker cane tips, disabled and handicapped hygiene adaptor more...
Phone: +86-(757)-8120-2180
FDA Registration: 3004194020
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Handicapped Cane (FDA Code: IPS), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), ...
Foshan Dongfang Medical Equipment Manufactory (ltd) manufactures products for disabled and handicapped peoples. We offer crutches, crutch and walker cane tips, disabled and handicapped hygiene adaptor more...
Gentry Hardware Products Co. Ltd. | Address: 103 Tong Leh Da Lie 1st Road, Zhongshan, Guang Dong 528414, China
Phone: +86-(760)-6955189
FDA Registration: 3003775119
Products: Wheelchair Accessories (FDA Code: KNO), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Mechanical Walker (FDA Code: ITJ), ...
Gentry Hardware Products Co. Ltd is a manufacturer of adjustable hospital hydraulic beds, mechanical walkers, transfer aids and wheelchair belts. more...
Phone: +86-(760)-6955189
FDA Registration: 3003775119
Products: Wheelchair Accessories (FDA Code: KNO), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), Mechanical Walker (FDA Code: ITJ), ...
Gentry Hardware Products Co. Ltd is a manufacturer of adjustable hospital hydraulic beds, mechanical walkers, transfer aids and wheelchair belts. more...
Trolli King (Holding) Ltd. | Address: No.5 Jahu Road, Fuchengao Village, Pin-Hu Town, Long-Gang District, Shenzhen, Guangdong 518111, China
Phone: +86-(755)-84015811
FDA Registration: 3003823002
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Crutch (FDA Code: IPR), Wheelchair Curb Climber (FDA Code: IMN), Wheelchair Pusher Cuff (FDA Code: INC), Chair with Casters (FDA Code: INM), ...
Trolli King (Holding) Ltd. provides crutches, manual beds and wheelchair accessories. more...
Phone: +86-(755)-84015811
FDA Registration: 3003823002
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Crutch (FDA Code: IPR), Wheelchair Curb Climber (FDA Code: IMN), Wheelchair Pusher Cuff (FDA Code: INC), Chair with Casters (FDA Code: INM), ...
Trolli King (Holding) Ltd. provides crutches, manual beds and wheelchair accessories. more...
Xidu Hardware&plastic Products Co.,Ltd | Address: No. 3 DongJi Road, DongGu, DongFeng, Zhongshan, Guangdong 528400, China
Phone: +86-(0)-13631129631
FDA Registration: 3007817029
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Manual Patient Transfer Device (FDA Code: FMR), Crutch (FDA Code: IPR), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Xidu Hardware&plastic Products Co.,Ltd specializes in producing crtuches, commode chairs, shower chairs, folding walkers and transfer bench. more...
Phone: +86-(0)-13631129631
FDA Registration: 3007817029
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Manual Patient Transfer Device (FDA Code: FMR), Crutch (FDA Code: IPR), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Xidu Hardware&plastic Products Co.,Ltd specializes in producing crtuches, commode chairs, shower chairs, folding walkers and transfer bench. more...
Changzhou Xiong Cheng Electronic Limited | Address: Rm 2, 4/f, High-Technic Service Centre, 158 Renmin East Road, Changzhou, Jiangsu 213000, China
Phone: +86-(519)-83030071
Products: Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Changzhou Xiong Cheng Electronic Limited focuses on disabled and handicapped hygiene adaptors. more...
Phone: +86-(519)-83030071
Products: Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Changzhou Xiong Cheng Electronic Limited focuses on disabled and handicapped hygiene adaptors. more...
Danyang Maxthai Medical Equipment Co., Ltd. | Address: No. 8, Xing Hu Road, Lianhu Industrial Park, Danyang City, Jiangsu 212300, China
www.jcxs.com | Send Inquiry | Phone: +86-(511)-86553318
FDA Registration: 3007019343
Products: Plastic Parts For Medical Devices, Injection Ports, Disposable Injectors, Piston Syringe (FDA Code: FMF), Rubber Component, Soft Rubber Pressure Pad, ...
Danyang Maxthai Medical Equipment Co., Ltd. produces rubber pistol for disposable syringes. Rubber pistons for disposable are made of natural rubber with imported equipment and technology. more...
www.jcxs.com | Send Inquiry | Phone: +86-(511)-86553318
FDA Registration: 3007019343
Products: Plastic Parts For Medical Devices, Injection Ports, Disposable Injectors, Piston Syringe (FDA Code: FMF), Rubber Component, Soft Rubber Pressure Pad, ...
Danyang Maxthai Medical Equipment Co., Ltd. produces rubber pistol for disposable syringes. Rubber pistons for disposable are made of natural rubber with imported equipment and technology. more...
Jiangsu Konsung Medical Equip Co Ltd | Address: No8, North Er Wei Road,Danyang Economy Development Zone, Danyang City, Jiangsu 212323, China
www.konsung.com | Send Inquiry | Phone: +86-(511)-86378666
FDA Registration: 3005720080
Products: Healthcare Service, Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Gas Cylinder Pressure Regulator (FDA Code: CAN), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Commode Chairs, ...
Jiangsu Konsung Medical Equip Co Ltd specializes in the production of healthcare instruments. Our product line comprises of stethoscopes, sphygmomanometers, ultrasonic nebulizer, oxygen cylinder, elec more...
www.konsung.com | Send Inquiry | Phone: +86-(511)-86378666
FDA Registration: 3005720080
Products: Healthcare Service, Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Gas Cylinder Pressure Regulator (FDA Code: CAN), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), Commode Chairs, ...
Jiangsu Konsung Medical Equip Co Ltd specializes in the production of healthcare instruments. Our product line comprises of stethoscopes, sphygmomanometers, ultrasonic nebulizer, oxygen cylinder, elec 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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