Limb Brace Orthosis Suppliers
Limit companies to: Worldwide USA
Jiundar Industrial Co., Ltd. | Address: No.9, Alley 2, Lane 252, San Jiun Street, Shulin City 238, Taiwan 
www.jiundar.com.tw | Send Inquiry | Phone: +886-(02)-2689-2907
FDA Registration: 3003855936
Products: Foams, Sports Medicine, Elastic Bandages (FDA Code: FQM), Medical Fabrics Products, Cast Shoe (FDA Code: IPG), Sports Medicine Apparels, ...
Jiundar Industrial Co., Ltd. specializes in the lamination of industrial fabric used in sports medicine and garments. Our products include laminate product, TPU foam and TPU heat melt. Our TPU film is more...
www.jiundar.com.tw | Send Inquiry | Phone: +886-(02)-2689-2907
FDA Registration: 3003855936
Products: Foams, Sports Medicine, Elastic Bandages (FDA Code: FQM), Medical Fabrics Products, Cast Shoe (FDA Code: IPG), Sports Medicine Apparels, ...
Jiundar Industrial Co., Ltd. specializes in the lamination of industrial fabric used in sports medicine and garments. Our products include laminate product, TPU foam and TPU heat melt. Our TPU film is more...
Irufa Industrial Group Co., Ltd. | Address: No. 32 Alley 182, Cheng-Ping, 7th St., Tainan City 708, Taiwan
www.irufa.com | Send Inquiry | Phone: +886-(6)-2993736
FDA Registration: 3002581790 Quality: ISO 9001 Certified
Products: External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), External Limb Component Shoulder Joint (FDA Code: IQQ), Limb Brace Orthosis (FDA Code: IQI), Pelvic Support Band (FDA Code: ISR), Radiological Eye Shield (FDA Code: IWS), ...
Irufa Industrial Group Co., Ltd. is a manufacturer of magnetic therapy products and cold hot therapy products. We are an ISO 9001:2000 certified company. The magnetic therapy improve the blood circula more...
www.irufa.com | Send Inquiry | Phone: +886-(6)-2993736
FDA Registration: 3002581790 Quality: ISO 9001 Certified
Products: External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), External Limb Component Shoulder Joint (FDA Code: IQQ), Limb Brace Orthosis (FDA Code: IQI), Pelvic Support Band (FDA Code: ISR), Radiological Eye Shield (FDA Code: IWS), ...
Irufa Industrial Group Co., Ltd. is a manufacturer of magnetic therapy products and cold hot therapy products. We are an ISO 9001:2000 certified company. The magnetic therapy improve the blood circula more...
Tien Jiang Enterprise Co., Ltd. | Address: 3f.,No.20, Lane 619, Chung Hwa Rd.,Yung Kang City, Tainan Hsien 710, Taiwan
www.tienjiang.com.tw | Send Inquiry | Phone: +886-(6)-2313-002
FDA Registration: 3003849847
Products: Elastic Bandages (FDA Code: FQM), Elastic Athletic Supports, Elastic Support Hosiery, Arm Supports (FDA Code: IOY), External Ankle Brace (FDA Code: ITW), Knee Crutch Pads, ...
Tien Jiang Enterprise Co., Ltd. focuses on medical supports. Our products include protective wears, knee pads, neoprene cinches, elastic knitted supports, bandages and neoprene supports. We offer neop more...
www.tienjiang.com.tw | Send Inquiry | Phone: +886-(6)-2313-002
FDA Registration: 3003849847
Products: Elastic Bandages (FDA Code: FQM), Elastic Athletic Supports, Elastic Support Hosiery, Arm Supports (FDA Code: IOY), External Ankle Brace (FDA Code: ITW), Knee Crutch Pads, ...
Tien Jiang Enterprise Co., Ltd. focuses on medical supports. Our products include protective wears, knee pads, neoprene cinches, elastic knitted supports, bandages and neoprene supports. We offer neop more...
Fushing Brothers & Co. | Address: 6F, No. 16, Sec. 5, Nanking East Road, Taipei 105, Taiwan
www.fushing.com | Send Inquiry | Phone: +886-(2)-276-21117
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Soft Sacroiliac Orthosis (FDA Code: IPW), ...
Fushing Brothers & Co. offers crutch tips and suction cups used in medical applications. more...
www.fushing.com | Send Inquiry | Phone: +886-(2)-276-21117
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Soft Sacroiliac Orthosis (FDA Code: IPW), ...
Fushing Brothers & Co. offers crutch tips and suction cups used in medical applications. more...
Tricare Medical Co., Ltd. | Address: 11f Dynasty Building, 155, Sec. 1, Keelung Road, Taipei 110, Taiwan
Phone: +886-(2)-27667588
FDA Registration: 3005597721
Products: Adhesive Bandages (FDA Code: KGX), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Adult Tongue Depressor (FDA Code: FMA), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), ...
Tricare Medical Co., Ltd. deals with medical devices and surgical instruments. We provide arm slings, forceps, ear speculums, injection cannulas, mechanical walker and disposable medical beds. We offe more...
Phone: +886-(2)-27667588
FDA Registration: 3005597721
Products: Adhesive Bandages (FDA Code: KGX), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Adult Tongue Depressor (FDA Code: FMA), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), ...
Tricare Medical Co., Ltd. deals with medical devices and surgical instruments. We provide arm slings, forceps, ear speculums, injection cannulas, mechanical walker and disposable medical beds. We offe more...
Excellence Sporting Goods Co., Ltd. | Address: 5 F., No. 18-3, Sec. 6, Minquan E. Road, Taipei 114, Taiwan
www.excellence-sport.com | Send Inquiry | Phone: +886-(2)-279-41122
Products: Therapeutic Medical Binder (FDA Code: MDR), External Ankle Brace (FDA Code: ITW), Limb Brace Orthosis (FDA Code: IQI), Reusable Hot /Cold Pack (FDA Code: IME), ...
Excellence Sporting Goods Co., Ltd. deals with orthopedic products. Our products include external ankle braces, limb brace orthosis, reusable hot/cold packs, and therapeutic medical binders. We provid more...
www.excellence-sport.com | Send Inquiry | Phone: +886-(2)-279-41122
Products: Therapeutic Medical Binder (FDA Code: MDR), External Ankle Brace (FDA Code: ITW), Limb Brace Orthosis (FDA Code: IQI), Reusable Hot /Cold Pack (FDA Code: IME), ...
Excellence Sporting Goods Co., Ltd. deals with orthopedic products. Our products include external ankle braces, limb brace orthosis, reusable hot/cold packs, and therapeutic medical binders. We provid more...
Chief Medical Co., Ltd. | Address: 5 F., No. 18-3, Sec. 6, Minquan East Road, Taipei 114, Taiwan
Phone: +886-(2)-28473243
Products: Arm Supports (FDA Code: IOY), Therapeutic Medical Binder (FDA Code: MDR), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Pelvic Support Band (FDA Code: ISR), ...
Chief Medical Co., Ltd. provides pelvic supports, brace knee points, therapeutic medical binders and arm supports. more...
Phone: +886-(2)-28473243
Products: Arm Supports (FDA Code: IOY), Therapeutic Medical Binder (FDA Code: MDR), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Pelvic Support Band (FDA Code: ISR), ...
Chief Medical Co., Ltd. provides pelvic supports, brace knee points, therapeutic medical binders and arm supports. more...
Special Protectors Co., Ltd. | Address: 2FL., No. 130, Shin Hu 3rd Road,Nei Hu District, Taipei 114, Taiwan
www.sp-supports.com | Send Inquiry | Phone: +886-(2)-27921812
FDA Registration: 9616914 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001, ISO 9002, CE Certified
Products: Cervicothoracic Lumbar Orthosis, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Lumbar Orthosis, Brace (FDA Code: IQE), Ankle Support, ...
Special Protectors Co., Ltd. is a manufacturer of support products. Our products include abdominal belts, abdominal belts for support, belts-orthopedic, arm sling, cervical collars, clavicle, brace do more...
www.sp-supports.com | Send Inquiry | Phone: +886-(2)-27921812
FDA Registration: 9616914 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~60 Quality: ISO 9001, ISO 9002, CE Certified
Products: Cervicothoracic Lumbar Orthosis, Adjustable Ankle Support, Air Ankle Support, Basic Ankle Support, Lumbar Orthosis, Brace (FDA Code: IQE), Ankle Support, ...
Special Protectors Co., Ltd. is a manufacturer of support products. Our products include abdominal belts, abdominal belts for support, belts-orthopedic, arm sling, cervical collars, clavicle, brace do more...
Huntex Corporation | Address: No. 35-3 Lane 165, Hsin Sheng S. Rd., Sec. 1, Taipei 106, Taiwan
www.huntex.com.tw | Send Inquiry | Phone: +886-(2)-27081337
FDA Registration: 1000328618
Products: Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Hand Splint and Component (FDA Code: ILH), External Brace Knee Joint (FDA Code: ITQ), Pelvic Support Band (FDA Code: ISR), Hernia Support (FDA Code: EXN), ...
Huntex Corporation is a manufacturer of medical products. Our product line includes magnetic health, neoprene and gel supports, durable medical equipment, bath & toilet aids, disposables, and pharmacy more...
www.huntex.com.tw | Send Inquiry | Phone: +886-(2)-27081337
FDA Registration: 1000328618
Products: Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Hand Splint and Component (FDA Code: ILH), External Brace Knee Joint (FDA Code: ITQ), Pelvic Support Band (FDA Code: ISR), Hernia Support (FDA Code: EXN), ...
Huntex Corporation is a manufacturer of medical products. Our product line includes magnetic health, neoprene and gel supports, durable medical equipment, bath & toilet aids, disposables, and pharmacy more...
Sun-Shine Land Intl. Ltd. | Address: 8th Fl. 69-10 Chung Cheng East Road, Sec 2, Tamsui, Taiwan
www.sunshineland.com.tw | Phone: +866-(2)-2809-5156
FDA Registration: 9710514
Products: Dressing Adaptor (FDA Code: ILD), Eating Utensil (FDA Code: ILC), Electric Therapeutic Massager (FDA Code: ISA), Solid Medication Dispenser (FDA Code: NXB), Pill Crusher/Cutter (FDA Code: OHY), Medication Reminder (FDA Code: NXQ), ...
Sun-Shine Land Intl. Ltd. specializes in walking aids and wheelchairs. Our product line includes rollater, 3-wheeled walker, walk stick cliip, light weight rollater, handle sticks, folding walker, sta more...
www.sunshineland.com.tw | Phone: +866-(2)-2809-5156
FDA Registration: 9710514
Products: Dressing Adaptor (FDA Code: ILD), Eating Utensil (FDA Code: ILC), Electric Therapeutic Massager (FDA Code: ISA), Solid Medication Dispenser (FDA Code: NXB), Pill Crusher/Cutter (FDA Code: OHY), Medication Reminder (FDA Code: NXQ), ...
Sun-Shine Land Intl. Ltd. specializes in walking aids and wheelchairs. Our product line includes rollater, 3-wheeled walker, walk stick cliip, light weight rollater, handle sticks, folding walker, sta more...
E-Life International Co., Ltd | Address: 4 F-3, No. 366, Zhonghe Rd., Zhonghe City 235, Taiwan
www.e-lifebracing.com | Send Inquiry | Phone: +886-(2)-29231516
FDA Registration: 3005885000 Quality: DIN ISO 9001 standard Certified
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Knee Joint (FDA Code: ITQ), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
E-Life International Co., Ltd is involved in the business of orthopedic braces and supports. We produce orthopedic products, such as functional knees, ankles, elbows, wrists, walkings, back & spine br more...
www.e-lifebracing.com | Send Inquiry | Phone: +886-(2)-29231516
FDA Registration: 3005885000 Quality: DIN ISO 9001 standard Certified
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), External Brace Knee Joint (FDA Code: ITQ), Temporary Training Splint (FDA Code: IQM), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
E-Life International Co., Ltd is involved in the business of orthopedic braces and supports. We produce orthopedic products, such as functional knees, ankles, elbows, wrists, walkings, back & spine br more...
Valentine International Limited | Address: 8th Floor, No. 149, Sec. 2, Ta Tung Road, Hsichih, Taipei Hsien 221, Taiwan
www.valentine-dynalife.com | Send Inquiry | Phone: +886-(2)-8692-6662
FDA Registration: 8022890
Products: Ice Bags (FDA Code: KYR), Infusion Stand (FDA Code: FOX), Crutch (FDA Code: IPR), Wheelchair Commode Attachment (FDA Code: INB), Chair with Casters (FDA Code: INM), Sterile Corrugated Rubber Sheath For Nonindwelling Catheter (FDA Code: EYT), ...
Valentine International Limited specializes in the development of medical products. Our products include wheelchairs, bathroom safety aids, mobility, rehabilitation, orthopedic products, furniture & e more...
www.valentine-dynalife.com | Send Inquiry | Phone: +886-(2)-8692-6662
FDA Registration: 8022890
Products: Ice Bags (FDA Code: KYR), Infusion Stand (FDA Code: FOX), Crutch (FDA Code: IPR), Wheelchair Commode Attachment (FDA Code: INB), Chair with Casters (FDA Code: INM), Sterile Corrugated Rubber Sheath For Nonindwelling Catheter (FDA Code: EYT), ...
Valentine International Limited specializes in the development of medical products. Our products include wheelchairs, bathroom safety aids, mobility, rehabilitation, orthopedic products, furniture & e more...
Glory Knitting Co., Ltd. | Address: No. 16, Lane 689, Sec 1, Jhongshan Rd., Yongjing Township, TW-CHA 51244, Taiwan
Products: Occlusive Wound Dressing (FDA Code: NAD), Medical Support Stocking (FDA Code: FQL), Skin Pressure Protector (FDA Code: FMP), Limb Brace Orthosis (FDA Code: IQI), ...
Glory Knitting Co., Ltd. specializes in offering occlusive wound dressing, medical support stocking and skin pressure protector. more...
Products: Occlusive Wound Dressing (FDA Code: NAD), Medical Support Stocking (FDA Code: FQL), Skin Pressure Protector (FDA Code: FMP), Limb Brace Orthosis (FDA Code: IQI), ...
Glory Knitting Co., Ltd. specializes in offering occlusive wound dressing, medical support stocking and skin pressure protector. more...
Paifu Industrial Co Ltd | Address: No.77, Lane 395,Sec.1 Chung Cheng N. Rd., Gueiren Hsiang, Tainan Hsien, TW-TNQ 71141, Taiwan
FDA Registration: 3005246958
Products: Medical Insoles (FDA Code: KYS), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Lumbosacral Orthosis (FDA Code: IPY), ...
Paifu Industrial Co Ltd specializes in providing knee, wrist and waist protection. more...
FDA Registration: 3005246958
Products: Medical Insoles (FDA Code: KYS), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Lumbosacral Orthosis (FDA Code: IPY), ...
Paifu Industrial Co Ltd specializes in providing knee, wrist and waist protection. more...
Long East International Corp. | Address: No. 78, Pingxing St., Beitun Dist.,, Taichung City, Taiwan, Taichung, TW-TXG 406, Taiwan
www.longeast.url.tw | Phone: +866-(4)-22422023
FDA Registration: 3007842751
Products: Arm Supports (FDA Code: IOY), Cast Shoe (FDA Code: IPG), Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Clavicle Splint (FDA Code: IQJ), External Brace Knee Joint (FDA Code: ITQ), ...
Long East International Corp. specializes in providing orthopedic and post operative products. Our products include ankle support, arm slinge & shoulder immobilizer, cervical collar, elbow support, kn more...
www.longeast.url.tw | Phone: +866-(4)-22422023
FDA Registration: 3007842751
Products: Arm Supports (FDA Code: IOY), Cast Shoe (FDA Code: IPG), Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Clavicle Splint (FDA Code: IQJ), External Brace Knee Joint (FDA Code: ITQ), ...
Long East International Corp. specializes in providing orthopedic and post operative products. Our products include ankle support, arm slinge & shoulder immobilizer, cervical collar, elbow support, kn more...
CR-UNO Industrial Co., Ltd. | Address: No. 1-23 Chou Zang Rd, Hi-Feng Li, Chin Swea, TW-TXQ, Taiwan
www.cruno.com.tw | Send Inquiry | Phone: +886-(4)-26202231
FDA Registration: 3008520652
Products: Neoprene Ankle Support, Neoprene Elbow Sleeve, Neoprene Back Support, Neoprene Gloves, Neoprene Lumbar Brace, Limb Brace Orthosis (FDA Code: IQI), ...
CR-UNO Industrial Co., Ltd. is a manufacturer of neoprene products. We offer neoprene gloves, supports and orthopedic braces. more...
www.cruno.com.tw | Send Inquiry | Phone: +886-(4)-26202231
FDA Registration: 3008520652
Products: Neoprene Ankle Support, Neoprene Elbow Sleeve, Neoprene Back Support, Neoprene Gloves, Neoprene Lumbar Brace, Limb Brace Orthosis (FDA Code: IQI), ...
CR-UNO Industrial Co., Ltd. is a manufacturer of neoprene products. We offer neoprene gloves, supports and orthopedic braces. more...
Camp Scandinavia Ab | Address: 38 Karbingatan, Helsingborg SE-254 67, Sweden
www.campscandinavia.se | Send Inquiry | Phone: +46-(42)-252700
FDA Registration: 8030901
Products: Cervical Thoracic Orthosis (FDA Code: IPT), Adhesive Foam Discs, Cast Component (FDA Code: LGF), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Abdominal Muscle Toners, ...
Camp Scandinavia Ab specializes in the production of orthopedic products. Our product line comprises of Toeoff® family, Combo, Kiddiegait ™, C.H.E.C.K™, S.W.A.S.H®, Kid-Dee-Lite&tr more...
www.campscandinavia.se | Send Inquiry | Phone: +46-(42)-252700
FDA Registration: 8030901
Products: Cervical Thoracic Orthosis (FDA Code: IPT), Adhesive Foam Discs, Cast Component (FDA Code: LGF), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Abdominal Muscle Toners, ...
Camp Scandinavia Ab specializes in the production of orthopedic products. Our product line comprises of Toeoff® family, Combo, Kiddiegait ™, C.H.E.C.K™, S.W.A.S.H®, Kid-Dee-Lite&tr more...
Pani Teresa Medica Sa | Address: Gutowo Male, Ul. Powidzka 50, Wrzesnia 62-300, Poland
www.pani-teresa.com.pl | Send Inquiry | Phone: +48-(61)-4388200
Quality: ISO 9001:2000 Certified
Products: Elastic Bandages (FDA Code: FQM), Medical Support Stocking (FDA Code: FQL), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Overhead Supported Arm Sling (FDA Code: ILE), Hernia Support (FDA Code: EXN), ...
Pani Teresa Medica Sa manufactures textile and knitted medical products used in medical care & prophylaxis. We also provide pharmaceutical and orthopedic products. Our ventilated abdominal belt protec more...
www.pani-teresa.com.pl | Send Inquiry | Phone: +48-(61)-4388200
Quality: ISO 9001:2000 Certified
Products: Elastic Bandages (FDA Code: FQM), Medical Support Stocking (FDA Code: FQL), External Brace Knee Joint (FDA Code: ITQ), Limb Brace Orthosis (FDA Code: IQI), Overhead Supported Arm Sling (FDA Code: ILE), Hernia Support (FDA Code: EXN), ...
Pani Teresa Medica Sa manufactures textile and knitted medical products used in medical care & prophylaxis. We also provide pharmaceutical and orthopedic products. Our ventilated abdominal belt protec more...
Foot Science International, Ltd. | Address: 26 Dakota Crescent, Christchurch, Canterbury 8042, New Zealand
www.formthotics.co.nz | Phone: +64-((0)3)-348-2115
FDA Registration: 3006158810
Products: Ankle Foot Orthosis, Dorsal Ankle Foot Orthosis, Limb Brace Orthosis (FDA Code: IQI), Foot Drop Orthosis (FDA Code: OHI), ...
Foot Science International, Ltd. manufactures and markets Formthotics™ brand foot orthotics. Our Formthotic insole is used to correct posture, control excess pronation, provide good arch support more...
www.formthotics.co.nz | Phone: +64-((0)3)-348-2115
FDA Registration: 3006158810
Products: Ankle Foot Orthosis, Dorsal Ankle Foot Orthosis, Limb Brace Orthosis (FDA Code: IQI), Foot Drop Orthosis (FDA Code: OHI), ...
Foot Science International, Ltd. manufactures and markets Formthotics™ brand foot orthotics. Our Formthotic insole is used to correct posture, control excess pronation, provide good arch support more...
Ambroise | Address: Palatijn 13, Enschede NL7521 PN, Netherlands
www.ambroise.nl | Send Inquiry | Phone: +31-(53)-4302836
FDA Registration: 3003883662
Products: Limb Brace Orthosis (FDA Code: IQI), Mechanical External Limb Component Hand (FDA Code: IRA), ...
Ambroise develops and manufactures products for posture and movement problems. This includes bracket systems for people with paralysis of arms or legs (orthotics) or products that replace body parts ( more...
www.ambroise.nl | Send Inquiry | Phone: +31-(53)-4302836
FDA Registration: 3003883662
Products: Limb Brace Orthosis (FDA Code: IQI), Mechanical External Limb Component Hand (FDA Code: IRA), ...
Ambroise develops and manufactures products for posture and movement problems. This includes bracket systems for people with paralysis of arms or legs (orthotics) or products that replace body parts ( more...
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FDA Code / Regulation: IQI / 890.3475
A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.
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. 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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