Hand Splint and Component Suppliers
Limit companies to: Worldwide USA
Lu Lu Sports Corp. | Address: 11 Tsu-Chiang Road, Nankang Ind. Park, Nan-Tou 540, Taiwan 
Phone: +886-(49)-226-2986
FDA Registration: 3003893701
Products: Arm Slings (FDA Code: ILI), Traction Accessories, Leg Straps (FDA Code: ILZ), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), Cast Shoe (FDA Code: IPG), Traction Accessories (FDA Code: ILZ), ...
Lu Lu Sports Corp. offers arm slings, arm supports, cast shoes, cervical orthosis, clavicle splints and crutches. We provide external ankle braces, brace knee joints and external inflatable extremity more...
Phone: +886-(49)-226-2986
FDA Registration: 3003893701
Products: Arm Slings (FDA Code: ILI), Traction Accessories, Leg Straps (FDA Code: ILZ), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), Cast Shoe (FDA Code: IPG), Traction Accessories (FDA Code: ILZ), ...
Lu Lu Sports Corp. offers arm slings, arm supports, cast shoes, cervical orthosis, clavicle splints and crutches. We provide external ankle braces, brace knee joints and external inflatable extremity more...
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), Cast Covers (FDA Code: KIA), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), ...
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), Cast Covers (FDA Code: KIA), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), ...
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...
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), Medical Support Stocking (FDA Code: FQL), Pelvic Traction Belt (FDA Code: HSQ), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), ...
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), Medical Support Stocking (FDA Code: FQL), Pelvic Traction Belt (FDA Code: HSQ), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), ...
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...
Masaki Trading Co., Ltd. | Address: 6th Floor, No. 554 Linsen North Rd., Taipei, Taiwan
Phone: +886-(757)-2240177
FDA Registration: 3008311900
Products: Pressure Tubing and Accessories (FDA Code: BYX), Medical Insoles (FDA Code: KYS), Non Prescription Sunglasses (FDA Code: HQY), Non-Powered Traction Apparatus (FDA Code: HST), Microsurgical Ear Pick (FDA Code: JYT), Hand Splint and Component (FDA Code: ILH), ...
Masaki Trading Co., Ltd. offers electric therapeutic massagers and external ankle braces. We also offer hand splint and component, lumbosacral orthosis, medical insoles & microsurgical ear pick. more...
Phone: +886-(757)-2240177
FDA Registration: 3008311900
Products: Pressure Tubing and Accessories (FDA Code: BYX), Medical Insoles (FDA Code: KYS), Non Prescription Sunglasses (FDA Code: HQY), Non-Powered Traction Apparatus (FDA Code: HST), Microsurgical Ear Pick (FDA Code: JYT), Hand Splint and Component (FDA Code: ILH), ...
Masaki Trading Co., Ltd. offers electric therapeutic massagers and external ankle braces. We also offer hand splint and component, lumbosacral orthosis, medical insoles & microsurgical ear pick. 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...
Mammon International Corp. | Address: 9f. No.185, Nanking E. Rd., Section 4, Taipei 10579, Taiwan
www.mammonmedical.com.tw | Send Inquiry | Phone: +886-(2)-27174777
FDA Registration: 9680104
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Lumbar Orthosis, Brace (FDA Code: IQE), Cast Shoe (FDA Code: IPG), Moist Heat Pack (FDA Code: IMA), Medical Insoles (FDA Code: KYS), ...
Mammon International Corp. is a manufacturer of orthopedic soft products. Our product line includes knee splints, cervical collars, rib & abdominal belts, elbow & knee supports and traction products. more...
www.mammonmedical.com.tw | Send Inquiry | Phone: +886-(2)-27174777
FDA Registration: 9680104
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Lumbar Orthosis, Brace (FDA Code: IQE), Cast Shoe (FDA Code: IPG), Moist Heat Pack (FDA Code: IMA), Medical Insoles (FDA Code: KYS), ...
Mammon International Corp. is a manufacturer of orthopedic soft products. Our product line includes knee splints, cervical collars, rib & abdominal belts, elbow & knee supports and traction products. 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), 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), ...
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), 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), ...
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: Occupational Back Support, Cervicothoracic Lumbar Orthosis, Adjustable Elbow Support, Shiatsu Back Support, Women's Back Support, Adjustable Back 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: Occupational Back Support, Cervicothoracic Lumbar Orthosis, Adjustable Elbow Support, Shiatsu Back Support, Women's Back Support, Adjustable Back 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...
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: Wheelchair Accessories (FDA Code: KNO), Urinals (FDA Code: FNP), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Bedpan (FDA Code: FOB), ...
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: Wheelchair Accessories (FDA Code: KNO), Urinals (FDA Code: FNP), Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), Infusion Stand (FDA Code: FOX), Bedpan (FDA Code: FOB), ...
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...
Kao Chen Enterprise Co., Ltd. | Address: No. 68, Lane 326, Sangang Rd., Longjin Village, Longjing, Township, Taichung Co. 434, Taiwan
www.softguards.com | Phone: +866-(4)-26308728
FDA Registration: 3004129296 Year Established: 1979
Products: Elastic Bandages (FDA Code: FQM), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), External Non-Inflatable Extremity Splint (FDA Code: FYH), Manual Cast Application and Removal Instrument (FDA Code: LGG), Drill Brace (FDA Code: HXY), ...
Kao Chen Enterprise Co., Ltd. manufactures and exports orthopedic supports/splints/protectors, rehabilitation products, health-care products and athletic supports. Our products are cervical collars, c more...
www.softguards.com | Phone: +866-(4)-26308728
FDA Registration: 3004129296 Year Established: 1979
Products: Elastic Bandages (FDA Code: FQM), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), External Non-Inflatable Extremity Splint (FDA Code: FYH), Manual Cast Application and Removal Instrument (FDA Code: LGG), Drill Brace (FDA Code: HXY), ...
Kao Chen Enterprise Co., Ltd. manufactures and exports orthopedic supports/splints/protectors, rehabilitation products, health-care products and athletic supports. Our products are cervical collars, c 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: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), Non-Powered Traction Apparatus (FDA Code: HST), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), ...
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: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), Non-Powered Traction Apparatus (FDA Code: HST), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), ...
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: Tongue Depressors (FDA Code: FMA), Blood pressure Cuffs (FDA Code: DXQ), Adhesive Bandages (FDA Code: KGX), Wheelchair Accessories (FDA Code: KNO), Cast Covers (FDA Code: KIA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
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: Tongue Depressors (FDA Code: FMA), Blood pressure Cuffs (FDA Code: DXQ), Adhesive Bandages (FDA Code: KGX), Wheelchair Accessories (FDA Code: KNO), Cast Covers (FDA Code: KIA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
Valentine International Limited specializes in the development of medical products. Our products include wheelchairs, bathroom safety aids, mobility, rehabilitation, orthopedic products, furniture & e 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: Elastic Bandages (FDA Code: FQM), 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), ...
Paifu Industrial Co Ltd specializes in providing knee, wrist and waist protection. more...
FDA Registration: 3005246958
Products: Elastic Bandages (FDA Code: FQM), 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), ...
Paifu Industrial Co Ltd specializes in providing knee, wrist and waist protection. more...
Ulrich Ag | Address: Movenstr 12, St. Gallen 9015, Switzerland
www.ulrich-swiss.ch | Send Inquiry | Phone: +41-(71)-314-6262
FDA Registration: 8039053 Employee Count: ~20 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Bulldog Clamps, Bulldog Clamps, Straight, Bulldog Clamps, Cross-action, ...
Ulrich Ag manufactures and distributes general & special surgical instruments and medical appliances. Our products include general & surgical instruments developed for surgeons. We offer servicing of more...
www.ulrich-swiss.ch | Send Inquiry | Phone: +41-(71)-314-6262
FDA Registration: 8039053 Employee Count: ~20 Quality: CE Certified
Products: Forceps (FDA Code: HTD), Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Bulldog Clamps, Bulldog Clamps, Straight, Bulldog Clamps, Cross-action, ...
Ulrich Ag manufactures and distributes general & special surgical instruments and medical appliances. Our products include general & surgical instruments developed for surgeons. We offer servicing of more...
Orthoservice Ag | Address: Rotzbergstr. 7, Stansstad 6362, Switzerland
www.orthoservice.com | Send Inquiry | Phone: +41-(41)-611-00-88
FDA Registration: 3004067876
Products: Cervical Collars, Knee Braces & Supports, Plastic Chin Rest, Tennis Elbow Strap, Arm Supports (FDA Code: IOY), Orthopaedic Instruments, ...
Orthoservice Ag produces and sells orthopedic products. We offer traction products for neck, back, shoulder, arm, hand, hip, knee, foot and toe. The neck products include Schanz cervical collars, Scha more...
www.orthoservice.com | Send Inquiry | Phone: +41-(41)-611-00-88
FDA Registration: 3004067876
Products: Cervical Collars, Knee Braces & Supports, Plastic Chin Rest, Tennis Elbow Strap, Arm Supports (FDA Code: IOY), Orthopaedic Instruments, ...
Orthoservice Ag produces and sells orthopedic products. We offer traction products for neck, back, shoulder, arm, hand, hip, knee, foot and toe. The neck products include Schanz cervical collars, Scha 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: Arm Slings (FDA Code: ILI), Hip Abduction Orthosis, Thermoplastic Splints, Thermoplastic Material, Cervical Thoracic Orthosis (FDA Code: IPT), Adhesive Foam Discs, ...
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: Arm Slings (FDA Code: ILI), Hip Abduction Orthosis, Thermoplastic Splints, Thermoplastic Material, Cervical Thoracic Orthosis (FDA Code: IPT), Adhesive Foam Discs, ...
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...
Clairemed CC | Address: Unit 1a De Waal Park, De Waal Road, Diep River, Cape Town, ZA-WC 7800, South Africa 
Phone: +27-(21)-7067260
Products: Hand and Thumb Splints, Adult Hand & Wrist Splints, Hand Splint and Component (FDA Code: ILH), Full Hand Splints, ...
Clairemed CC specializes in offering hand splints and components. more...
Phone: +27-(21)-7067260
Products: Hand and Thumb Splints, Adult Hand & Wrist Splints, Hand Splint and Component (FDA Code: ILH), Full Hand Splints, ...
Clairemed CC specializes in offering hand splints and components. more...
QSA Surgical (Pvt) Ltd. | Address: Ghuinke Daska Road .P.O.Box 1094, Sialkot 051310, Pakistan
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
Send Inquiry | Phone: +92-(432)-52 6387/6487/6587
FDA Registration: 8040233
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Hooks (FDA Code: KIK), ...
QSA Surgical (Pvt) Ltd. specializes in surgical and dental instruments. Our product line includes amalgam carvers, dental cements, dental elevators, dental waxes, orthodonic band pashers, surgical spa more...
The Mughal Surgical (Pvt) Ltd | Address: C-95 Industrial Estate, P.O.Box 274, Punjab Province, Sialkot, Punjab 51340, Pakistan
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
Technimen Skillers | Address: Small Indus Estate, Sialkot, Punjab 51340, Pakistan
Phone: +92-(523)-561772
FDA Registration: 3001620590
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Scalpel Handle (FDA Code: GDZ), Ligature Carrier Set (FDA Code: GEJ), ...
Technimen Skillers is a manufacturer of air conduction hearing aids, blood collection lancets, general & plastic surgery forceps, ophthalmic headband mirrors, arm slings, ear suction tubes, scalpel ha more...
Phone: +92-(523)-561772
FDA Registration: 3001620590
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Scalpel Handle (FDA Code: GDZ), Ligature Carrier Set (FDA Code: GEJ), ...
Technimen Skillers is a manufacturer of air conduction hearing aids, blood collection lancets, general & plastic surgery forceps, ophthalmic headband mirrors, arm slings, ear suction tubes, scalpel ha more...
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FDA Code / Regulation: ILH / 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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