Transfer Aid Suppliers
Limit companies to: Worldwide USA
Guangzhou Fortunique Ltd. | Address: Block B 2, Zhou Shan Gang, Shi Bei Industrial Ave, Pan Yu Dist., Guangzhou 511410, China 
FDA Registration: 3003915904
Products: Patient Examination Gowns and Capes (FDA Code: FME), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), Bone Clamp (FDA Code: HXD), Traction Accessories, Leg Straps (FDA Code: ILZ), Examination Gown (FDA Code: FME), ...
Guangzhou Fortunique Ltd. is a contract manufacturer of surgical and medical products. Our product line consists of arm slings, corrective shoe orthosis, disposable medical beds, surgical cameras, han more...
FDA Registration: 3003915904
Products: Patient Examination Gowns and Capes (FDA Code: FME), Arm Slings (FDA Code: ILI), Ice Bags (FDA Code: KYR), Bone Clamp (FDA Code: HXD), Traction Accessories, Leg Straps (FDA Code: ILZ), Examination Gown (FDA Code: FME), ...
Guangzhou Fortunique Ltd. is a contract manufacturer of surgical and medical products. Our product line consists of arm slings, corrective shoe orthosis, disposable medical beds, surgical cameras, han more...
Shanghai Shunlong Physical Therapy Equipment Co.Ltd | Address: No. 259 Jiugan Road, Sijing Town,Songjiang District, Shanghai 201601, China
www.shunlong.net.cn | Send Inquiry | Phone: +86-(21)-,57626202
FDA Registration: 3003910843
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), ...
Shanghai Shunlong Physical Therapy Equipment Co.Ltd offers ambulatory products, beds & bedrelated products, transfer chairs and light weight wheel chairs. Our ambulatory products include standard stee more...
www.shunlong.net.cn | Send Inquiry | Phone: +86-(21)-,57626202
FDA Registration: 3003910843
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Manual Beds (FDA Code: FNJ), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), ...
Shanghai Shunlong Physical Therapy Equipment Co.Ltd offers ambulatory products, beds & bedrelated products, transfer chairs and light weight wheel chairs. Our ambulatory products include standard stee more...
Apex Hme Corp. | Address: No.1879, Daye Road, Wuqiao Town, Fengxian, Shanghai, China
Phone: +886-(2)-22683100
Products: Electrode Cables (FDA Code: IKD), Wheelchair Accessories (FDA Code: KNO), Manual Beds (FDA Code: FNJ), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Apex Hme Corp. provides electrode cables, manual beds, wheelchair armrests, mechanical walkers and electrical powered muscle simulators. more...
Phone: +886-(2)-22683100
Products: Electrode Cables (FDA Code: IKD), Wheelchair Accessories (FDA Code: KNO), Manual Beds (FDA Code: FNJ), Alternating Pressure Air Flotation Mattress (FDA Code: FNM), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Apex Hme Corp. provides electrode cables, manual beds, wheelchair armrests, mechanical walkers and electrical powered muscle simulators. more...
Taicang Yuanjie Machinery Products Co., Ltd. | Address: N0 96,Xingang Road,Xintang District, Liuhe Town, Taicang 215436, China
Phone: +86-(512)-53623698
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Taicang Yuanjie Machinery Products Co., Ltd. offers transfer aids for disabled/handicapped patients. more...
Phone: +86-(512)-53623698
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Taicang Yuanjie Machinery Products Co., Ltd. offers transfer aids for disabled/handicapped patients. more...
Suzhou Jiagao Shoes Co., Ltd. | Address: Zhongshi Rd(w), Ludu Town, Taicang Suzhou, Jiangsu 215412, China
Phone: +86-(512)-534-58751
FDA Registration: 3006089236
Products: Foley Catheter Holders (FDA Code: EYJ), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Ureteral Catheter Holder (FDA Code: EYJ), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Suzhou Jiagao Shoes Co., Ltd. provides abdominal binders, arm slings, arm supports, cervical orthosis, corrective shoe orthosis, disposable medical beds, Foley's catheter holders, external ankle brace more...
Phone: +86-(512)-534-58751
FDA Registration: 3006089236
Products: Foley Catheter Holders (FDA Code: EYJ), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Ureteral Catheter Holder (FDA Code: EYJ), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Suzhou Jiagao Shoes Co., Ltd. provides abdominal binders, arm slings, arm supports, cervical orthosis, corrective shoe orthosis, disposable medical beds, Foley's catheter holders, external ankle brace more...
Ariel Textile Intl. Corp. | Address: 2th Fl.,143,Section 2, Ming Sheng E. Rd., Taipei, China
Phone: +86-(847)-6820224
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Ariel Textile Intl. Corp. deals with examination gowns, non-surgical isolation gowns, patient examination gowns, capes and transfer aids for disabled/handicapped. more...
Phone: +86-(847)-6820224
Products: Patient Examination Gowns and Capes (FDA Code: FME), Examination Gown (FDA Code: FME), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Non-Surgical Isolation Gown (FDA Code: OEA), ...
Ariel Textile Intl. Corp. deals with examination gowns, non-surgical isolation gowns, patient examination gowns, capes and transfer aids for disabled/handicapped. more...
Promedtek Plastics And Metal Factory | Address: Yankong Bridge Section, Guang Shan Gong Lu, Zengcheng, Guangdong, Prc., Zengcheng 511370, China
Phone: +86-(908)-2168849
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Promedtek Plastics And Metal supplies a range of products for disabled and handicapped. Our products include wheelchair footrests, transfer aids and hygiene adaptors. more...
Phone: +86-(908)-2168849
Products: Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Promedtek Plastics And Metal supplies a range of products for disabled and handicapped. Our products include wheelchair footrests, transfer aids and hygiene adaptors. more...
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), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Infusion Stand (FDA Code: FOX), Manual Patient Transfer Device (FDA Code: FMR), ...
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), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Infusion Stand (FDA Code: FOX), Manual Patient Transfer Device (FDA Code: FMR), ...
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...
Prius Healthcare Solution (Shanghai) Ltd. | Address: Rm2606, No.555 Loushanguan Rd., Shanghai, CN-31 200051, China
Products: Air Mattress, Air Mattresses, Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Cast Shoe (FDA Code: IPG), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Prius Healthcare Solution (Shanghai) Ltd. is a manufacturer and supplier of medical equipment. Our product line includes air & foam mattress and seat cushion. Our AltAir 1000 mattress replacement syst more...
Products: Air Mattress, Air Mattresses, Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Cast Shoe (FDA Code: IPG), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Prius Healthcare Solution (Shanghai) Ltd. is a manufacturer and supplier of medical equipment. Our product line includes air & foam mattress and seat cushion. Our AltAir 1000 mattress replacement syst more...
Danyang Jinqiao Gymnastic Apparatus Factory | Address: Fangxian Town, Jiangsu Province at DanYang, CN-32 212321, China
www.js-jinqiao.com | Send Inquiry | Phone: +0086-(0511)-6466666
Products: Manual Beds (FDA Code: FNJ), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), Infusion Stand (FDA Code: FOX), Medical Chair and Table (FDA Code: KMN), ...
Danyang Jinqiao Gymnastic Apparatus Factory specializes in offering medical devices and gymnastic apparatus. We also provide weight lifting benches, exercycles & ellipticals, multigyms, press machine, more...
www.js-jinqiao.com | Send Inquiry | Phone: +0086-(0511)-6466666
Products: Manual Beds (FDA Code: FNJ), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), Infusion Stand (FDA Code: FOX), Medical Chair and Table (FDA Code: KMN), ...
Danyang Jinqiao Gymnastic Apparatus Factory specializes in offering medical devices and gymnastic apparatus. We also provide weight lifting benches, exercycles & ellipticals, multigyms, press machine, 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: Manual Beds (FDA Code: FNJ), Cast Shoe (FDA Code: IPG), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), ...
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: Manual Beds (FDA Code: FNJ), Cast Shoe (FDA Code: IPG), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Wheelchair Footrests (FDA Code: IMM), Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), ...
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...
Reborn Medical Co., Ltd. | Address: Guangfeng Wei,Yumin Village,, Dongsheng County, Zhongshan City, Guangdong Province, CN-44 528414, China
FDA Registration: 3005783092
Products: Folding Walkers, Folding Walkers & Accessories, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), ...
Reborn Medical Co., Ltd. specializes in offering medical equipment, folding walkers and commode chair series. more...
FDA Registration: 3005783092
Products: Folding Walkers, Folding Walkers & Accessories, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Handicapped Cane (FDA Code: IPS), ...
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), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
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), Crutch and Walker Cane Tips (FDA Code: INP), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), ...
Zhongshan Juncheng Hardware Co., Ltd. manufactures medical recovery instruments. We offer bath stools, telescope crutches, walking sticks and canes. 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), Manual Beds (FDA Code: FNJ), 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), ...
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), Manual Beds (FDA Code: FNJ), 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), ...
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...
Vincent Medical (dong Guan) Mfg. Co., Ltd. | Address: 45-46 Shabu Industrial Zone, Qiaolong District,Tangxia, Dong Guan, Guang Dong 523730, China
www.vincent-raya.com | Phone: +86-(769)-8772 3899
FDA Registration: 3004050971 Quality: ISO 9001 , ISO 13485,ISO11135,CE Certified
Products: Oxygen Masks (FDA Code: BYG), Adhesive Bandages (FDA Code: KGX), Reservoir Bag (FDA Code: BTC), Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Vincent Medical (dong Guan) Mfg. Co., Ltd. manufactures various types of medical devices. Our product line includes medical disposables, inspired respiratory medical products and cut & sew products. O more...
www.vincent-raya.com | Phone: +86-(769)-8772 3899
FDA Registration: 3004050971 Quality: ISO 9001 , ISO 13485,ISO11135,CE Certified
Products: Oxygen Masks (FDA Code: BYG), Adhesive Bandages (FDA Code: KGX), Reservoir Bag (FDA Code: BTC), Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), ...
Vincent Medical (dong Guan) Mfg. Co., Ltd. manufactures various types of medical devices. Our product line includes medical disposables, inspired respiratory medical products and cut & sew products. O 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), Transfer Aid (FDA Code: IKX), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Manual Patient Rotation Bed (FDA Code: INY), Mechanical Walker (FDA Code: ITJ), ...
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), Transfer Aid (FDA Code: IKX), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Manual Patient Rotation Bed (FDA Code: INY), Mechanical Walker (FDA Code: ITJ), ...
Sun Zing Plastic Ironware Co., Ltd. is engaged in the business of bed rails, rollators, rolling walkers and bath rails. 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: Wheelchairs, Bathroom accessories, Rollators, Shower Chairs, Bathroom Chairs, Quad Canes, ...
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: Wheelchairs, Bathroom accessories, Rollators, Shower Chairs, Bathroom Chairs, Quad Canes, ...
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...
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), Adjustable Hospital Hydraulic Bed (FDA Code: FNK), Handicapped Cane (FDA Code: IPS), ...
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), Adjustable Hospital Hydraulic Bed (FDA Code: FNK), Handicapped Cane (FDA Code: IPS), ...
Gentry Hardware Products Co. Ltd is a manufacturer of adjustable hospital hydraulic beds, mechanical walkers, transfer aids and wheelchair belts. 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), Infusion Stand (FDA Code: FOX), Manual Patient Transfer Device (FDA Code: FMR), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), ...
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), Infusion Stand (FDA Code: FOX), Manual Patient Transfer Device (FDA Code: FMR), Handicapped Cane (FDA Code: IPS), Crutch (FDA Code: IPR), ...
Xidu Hardware&plastic Products Co.,Ltd specializes in producing crtuches, commode chairs, shower chairs, folding walkers and transfer bench. more...
Concorde Medical Products, Co, Ltd. | Address: Huadu Industry Zone, Lijia Town, Wujin, Changzhou, Jiangsu 213173, China
Phone: +86-(815)-3850100
Products: Forceps (FDA Code: HTD), First Aid Kits, Ear Curette (FDA Code: JYG), Bone Clamp (FDA Code: HXD), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Concorde Medical Products, Co., Ltd. is engaged in the production of disposable medical products. Our products are disposable razors, ear curettes, umbilical cord clamps, cord clamp clippers, crutch d more...
Phone: +86-(815)-3850100
Products: Forceps (FDA Code: HTD), First Aid Kits, Ear Curette (FDA Code: JYG), Bone Clamp (FDA Code: HXD), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Concorde Medical Products, Co., Ltd. is engaged in the production of disposable medical products. Our products are disposable razors, ear curettes, umbilical cord clamps, cord clamp clippers, crutch d more...
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FDA Code / Regulation: IKX / 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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