Hand Splint and Component Suppliers
Limit companies to: Worldwide USA
Sporlastic Gmbh | Address: Weberstrabe 1, Nurtingen D-72622, Germany 
www.sporlastic.de | Send Inquiry | Phone: +49-(7022)-705181
FDA Registration: 3005083016 Quality: ISO 9001:2000 Certified
Products: Cervical Collars, Braces, Elastic Wrist Support, Cervical Neck Collar, Abdominal Orthosis (FDA Code: KTD), Hand Splint and Component (FDA Code: ILH), ...
Sporlastic Gmbh focuses on the production of orthopedic products and braces. We provide Cervi-hit, that is anatomically designed cervical support with reinforcement, can be worn day and night, relieve more...
www.sporlastic.de | Send Inquiry | Phone: +49-(7022)-705181
FDA Registration: 3005083016 Quality: ISO 9001:2000 Certified
Products: Cervical Collars, Braces, Elastic Wrist Support, Cervical Neck Collar, Abdominal Orthosis (FDA Code: KTD), Hand Splint and Component (FDA Code: ILH), ...
Sporlastic Gmbh focuses on the production of orthopedic products and braces. We provide Cervi-hit, that is anatomically designed cervical support with reinforcement, can be worn day and night, relieve more...
Bort Medical | Address: 39 Ziegeleistrasse, Weinstadt-Benzach 71384, Germany
www.bort.de | Phone: +49-(7151)-992000
FDA Registration: 1000649241
Products: Elastic Bandages (FDA Code: FQM), Lumbar Orthosis, Brace (FDA Code: IQE), Hand Splint and Component (FDA Code: ILH), Flotation Cushion (FDA Code: KIC), Knee Cage (FDA Code: ITM), Hernia Support (FDA Code: EXN), ...
Bort Medical deals with medical aids. We provide neck, arm, finger, thumb, body, knee, ankle, foot and home care/OTC products. Our Stabilo® orthopaedic cervical support is used for operations of t more...
www.bort.de | Phone: +49-(7151)-992000
FDA Registration: 1000649241
Products: Elastic Bandages (FDA Code: FQM), Lumbar Orthosis, Brace (FDA Code: IQE), Hand Splint and Component (FDA Code: ILH), Flotation Cushion (FDA Code: KIC), Knee Cage (FDA Code: ITM), Hernia Support (FDA Code: EXN), ...
Bort Medical deals with medical aids. We provide neck, arm, finger, thumb, body, knee, ankle, foot and home care/OTC products. Our Stabilo® orthopaedic cervical support is used for operations of t more...
Allsurg Medizintechnik UG | Address: Bachstr 8,, County Is Tuttlingen, Wurmlingen 78573, Germany
Phone: +49-(7461)-9107211
Products: Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Metal Vaginal Speculum (FDA Code: HDF), Curettes (FDA Code: HTF), ENT Mirror (FDA Code: KAI), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Phone: +49-(7461)-9107211
Products: Bone Clamp (FDA Code: HXD), General & Plastic Surgery Forceps (FDA Code: GEN), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), Metal Vaginal Speculum (FDA Code: HDF), Curettes (FDA Code: HTF), ENT Mirror (FDA Code: KAI), ...
Allsurg Medizintechnik UG provides medical supplies. more...
Djo France Sas | Address: European Cargo Center, Mouguerre 64990, France
www.anot-ortho.com | Phone: +33-(05)-59528690
FDA Registration: 3007502541
Products: Finger Splints, Cervical Collars, Universal Wrist Splint, Cryotherapy Unit (FDA Code: HQA), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), ...
Djo France Sas deals with treatment of pain. Our products are ligament, post-operative splinting, bracing, splints gonarthritis/OA, walkers, leg lifters and ankle braces. We offer stabilizing splint s more...
www.anot-ortho.com | Phone: +33-(05)-59528690
FDA Registration: 3007502541
Products: Finger Splints, Cervical Collars, Universal Wrist Splint, Cryotherapy Unit (FDA Code: HQA), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), ...
Djo France Sas deals with treatment of pain. Our products are ligament, post-operative splinting, bracing, splints gonarthritis/OA, walkers, leg lifters and ankle braces. We offer stabilizing splint s more...
Allegiance Healthcare Corp. | Address: Zona Franca Las Americas, Autlas Americas Km 22 1-2 Sur, Santo Domingo, Dominican Republic
Phone: 847-473-1500
FDA Registration: 9680904
Products: Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Amniotic Fluid Sampler (FDA Code: HIO), Biopsy Needle Kit (FDA Code: FCG), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Phone: 847-473-1500
FDA Registration: 9680904
Products: Biopsy Instruments (FDA Code: KNW), Biopsy Instruments (FDA Code: KNW), Catheter Needle (FDA Code: GCB), Surgical Needle Guide (FDA Code: GDF), Amniotic Fluid Sampler (FDA Code: HIO), Biopsy Needle Kit (FDA Code: FCG), ...
Allegiance Healthcare Corp are providers of introducer needle reusables, disposable bome marrow biopsy needles and trays. more...
Kamex International S.A. | Address: Calle 161a No 19a-77, Bogota, Colombia
Phone: +57-(1)-6054211
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Abdominal Orthosis (FDA Code: KTD), Cervical Orthosis (FDA Code: IQK), Clavicle Splint (FDA Code: IQJ), Lumbosacral Orthosis (FDA Code: IPY), Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), ...
Kamex International S.A. provides abdominal, cervical, lumbosacral, rigid cervical-thoracic, and soft rib fracture orthosis. We also provide arm supports, clavicle splint, external ankle brace & brace more...
Phone: +57-(1)-6054211
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Abdominal Orthosis (FDA Code: KTD), Cervical Orthosis (FDA Code: IQK), Clavicle Splint (FDA Code: IQJ), Lumbosacral Orthosis (FDA Code: IPY), Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), ...
Kamex International S.A. provides abdominal, cervical, lumbosacral, rigid cervical-thoracic, and soft rib fracture orthosis. We also provide arm supports, clavicle splint, external ankle brace & brace more...
Klarity Medical & Equipment Co., Ltd. | Address: 4 Fl., 1st Bldg. Guangzhou, Scienctech Park, No.9, Lan Yu, 4th Rd., Getdd, Guangzhou 510730, China 
www.klarity-medical.com | Send Inquiry | Phone: +86-(20)-82226380
FDA Registration: 3003803149 Quality: ISO 9001, ISO 13485 Certified
Products: Medical Thermometers, Nasal Splints (FDA Code: EPP), Plastic Splints, Hand Splint and Component (FDA Code: ILH), Medical Linear Accelerator (FDA Code: IYE), Splint Wraps, ...
Klarity Medical & Equipment Co., Ltd. deals with medical thermoplastic products. We provide medical splint that includes Contour Color™, Klarity Pro™ and Contour Pro™ splints. Our Kl more...
www.klarity-medical.com | Send Inquiry | Phone: +86-(20)-82226380
FDA Registration: 3003803149 Quality: ISO 9001, ISO 13485 Certified
Products: Medical Thermometers, Nasal Splints (FDA Code: EPP), Plastic Splints, Hand Splint and Component (FDA Code: ILH), Medical Linear Accelerator (FDA Code: IYE), Splint Wraps, ...
Klarity Medical & Equipment Co., Ltd. deals with medical thermoplastic products. We provide medical splint that includes Contour Color™, Klarity Pro™ and Contour Pro™ splints. Our Kl more...
Dalian Rongbang Medical Healthy Devices Co., Ltd. | Address: Beihai Economical Development Zone,Dalianwan Town,Ganjingzi Dist, Dalian 116113, China
www.rb-medical.com | Send Inquiry | Phone: +86-(411)-87112755, 87112155
FDA Registration: 3003890648 Quality: ISO 9001:2000 & ISO 13485:2003, CE Certified
Products: Surgical Dress (FDA Code: FYE), Operating Room Shoe Cover (FDA Code: FXP), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Sterile Absorbent Tipped Applicator (FDA Code: KXG), Ophthalmic Spoon (FDA Code: HNB), Skin Protectant Liquid Bandage (FDA Code: NEC), ...
Dalian Rongbang Medical Healthy Devices Co., Ltd. specializes in the manufacture and sale of disposable medical devices. We manufacture and distribute medical devices including transport swabs, alcoho more...
www.rb-medical.com | Send Inquiry | Phone: +86-(411)-87112755, 87112155
FDA Registration: 3003890648 Quality: ISO 9001:2000 & ISO 13485:2003, CE Certified
Products: Surgical Dress (FDA Code: FYE), Operating Room Shoe Cover (FDA Code: FXP), Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF), Sterile Absorbent Tipped Applicator (FDA Code: KXG), Ophthalmic Spoon (FDA Code: HNB), Skin Protectant Liquid Bandage (FDA Code: NEC), ...
Dalian Rongbang Medical Healthy Devices Co., Ltd. specializes in the manufacture and sale of disposable medical devices. We manufacture and distribute medical devices including transport swabs, alcoho more...
Deqing Cathaya Sporting Goods Co., Ltd. | Address: Cathaya Industiral Zone, Block No.6, Wukang, Deqing Huzhou 313200, China
Phone: +86-(571)-85098111
FDA Registration: 3006973677
Products: Arm Supports (FDA Code: IOY), 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), ...
Deqing Cathaya Sporting Goods Co., Ltd. supplies arm support products. We provide hand splints and components, external ankle braces, limb brace orthosis and external brace knee joints. more...
Phone: +86-(571)-85098111
FDA Registration: 3006973677
Products: Arm Supports (FDA Code: IOY), 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), ...
Deqing Cathaya Sporting Goods Co., Ltd. supplies arm support products. We provide hand splints and components, external ankle braces, limb brace orthosis and external brace knee joints. more...
Shanghai Qiu Jing Suitcase Co., Ltd. | Address: No. 28 Building 3, 250 Lane Dalian W. Road, Hong Kou District , Shanghai 200083, China
Phone: +86-(21)-323-8766970
Products: Traction Splint (FDA Code: HSP), Hand-Carried Stretcher (FDA Code: FPP), Exercise Component (FDA Code: IOD), Limb Brace Orthosis (FDA Code: IQI), Limb Cover (FDA Code: IPM), Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), ...
Shanghai Qiu Jing Suitcase Co., Ltd. is a provider of exercise bands & tubes, hand & wrist splints, immobilizers, limb covers and stretchers. more...
Phone: +86-(21)-323-8766970
Products: Traction Splint (FDA Code: HSP), Hand-Carried Stretcher (FDA Code: FPP), Exercise Component (FDA Code: IOD), Limb Brace Orthosis (FDA Code: IQI), Limb Cover (FDA Code: IPM), Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), ...
Shanghai Qiu Jing Suitcase Co., Ltd. is a provider of exercise bands & tubes, hand & wrist splints, immobilizers, limb covers and stretchers. more...
Nantong Ankang Medical Co Ltd | Address: Wangxiangxinlu Nantong, Jiangsu 55364, China
Phone: +86-(513)-85501966
Products: Arm Slings (FDA Code: ILI), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Medical Absorbent Fiber (FDA Code: FRL), Burn Sheet (FDA Code: FPY), Mattress Cover (FDA Code: FMW), Hand Splint and Component (FDA Code: ILH), ...
Nantong Ankang Medical Co Ltd focuses on arm slings, burn sheets, hand splint components, mattress covers, medical absorbent fibers and nonresorbable for external use gauzes/sponges. more...
Phone: +86-(513)-85501966
Products: Arm Slings (FDA Code: ILI), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), Medical Absorbent Fiber (FDA Code: FRL), Burn Sheet (FDA Code: FPY), Mattress Cover (FDA Code: FMW), Hand Splint and Component (FDA Code: ILH), ...
Nantong Ankang Medical Co Ltd focuses on arm slings, burn sheets, hand splint components, mattress covers, medical absorbent fibers and nonresorbable for external use gauzes/sponges. more...
Jintan Kangyi Medical Co. Ltd | Address: No. 160 Jin Sheng Dong Lu, Jintan City 213200, China
Phone: +86-(8651)-92280446
Products: Arm Slings (FDA Code: ILI), Battery-Powered Medical Examination Light (FDA Code: KYT), Disposable Medical Bed (FDA Code: KME), Burn Sheet (FDA Code: FPY), Hand-Carried Stretcher (FDA Code: FPP), Hand Splint and Component (FDA Code: ILH), ...
Jintan Kangyi Medical Co. Ltd deals with arm slings, disposable medical beds, infusion stands and patient position supports. We offer battery-powered medical examination lights, hand splints & compone more...
Phone: +86-(8651)-92280446
Products: Arm Slings (FDA Code: ILI), Battery-Powered Medical Examination Light (FDA Code: KYT), Disposable Medical Bed (FDA Code: KME), Burn Sheet (FDA Code: FPY), Hand-Carried Stretcher (FDA Code: FPP), Hand Splint and Component (FDA Code: ILH), ...
Jintan Kangyi Medical Co. Ltd deals with arm slings, disposable medical beds, infusion stands and patient position supports. We offer battery-powered medical examination lights, hand splints & compone more...
Medsource Healthcare Products Inc. | Address: Room 501 Bindanyuan 8 Dong Jinguhuachen Jintan City,Jiangsu Province China, Jintan City, Jiangsu 213200, China
Phone: +86-(519)-2310992
Products: Nasopharyngeal Airways (FDA Code: BTQ), Oval Eye Pads (FDA Code: HMP), Ophthalmic Eye Pad (FDA Code: HMP), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Non-Ventilatory Medicinal Nebulizer/Atomizer (FDA Code: CCQ), Patient Restraint Stretcher (FDA Code: NZD), ...
Medsource Healthcare Products Inc. focuses on adhesive bandages, anesthesiology oropharyngeal airways, arm slings and battery-powered medical examination lights. We offer burn sheets, cardiopulmonary more...
Phone: +86-(519)-2310992
Products: Nasopharyngeal Airways (FDA Code: BTQ), Oval Eye Pads (FDA Code: HMP), Ophthalmic Eye Pad (FDA Code: HMP), Anesthesiology Oropharyngeal Airway (FDA Code: CAE), Non-Ventilatory Medicinal Nebulizer/Atomizer (FDA Code: CCQ), Patient Restraint Stretcher (FDA Code: NZD), ...
Medsource Healthcare Products Inc. focuses on adhesive bandages, anesthesiology oropharyngeal airways, arm slings and battery-powered medical examination lights. We offer burn sheets, cardiopulmonary more...
Goodway (Far East) Industrial, Ltd. | Address: Room 1510, Nan Fung, Commercial Ctr.,19 Lam Lok St., Kowloon Bay,Hong Kong, China
Phone: +86-(852)-275-56521
Products: Ophthalmic Eye Shield (FDA Code: HOY), Hand Splint and Component (FDA Code: ILH), ...
Goodway (Far East) Industrial, Ltd focuses on hand splints and components & ophthalmic eye shields. more...
Phone: +86-(852)-275-56521
Products: Ophthalmic Eye Shield (FDA Code: HOY), Hand Splint and Component (FDA Code: ILH), ...
Goodway (Far East) Industrial, Ltd focuses on hand splints and components & ophthalmic eye shields. more...
Po Wah Co.,Ltd. | Address: 1/f.,Tung Lee Industrial Building, 9 Lai Yip St., Kwun Tong, Kowloon, Hong Kong, China
Phone: +852-(283)-87667
FDA Registration: 1000539597
Products: Visual Acuity Charts (FDA Code: HOX), Non Dental Irrigating Syringe (FDA Code: KYZ), ENT Applicator (FDA Code: KCJ), Hemorrhoid Cushion (FDA Code: LRL), Solid Medication Dispenser (FDA Code: NXB), Pill Crusher/Cutter (FDA Code: OHY), ...
Po Wah Co.,Ltd deals with bite blocks, disabled grooming adaptors, ENT applicators, graduated liquid medication containers, hand splints and components. We offer hemorrhoid cushions, microscope slide more...
Phone: +852-(283)-87667
FDA Registration: 1000539597
Products: Visual Acuity Charts (FDA Code: HOX), Non Dental Irrigating Syringe (FDA Code: KYZ), ENT Applicator (FDA Code: KCJ), Hemorrhoid Cushion (FDA Code: LRL), Solid Medication Dispenser (FDA Code: NXB), Pill Crusher/Cutter (FDA Code: OHY), ...
Po Wah Co.,Ltd deals with bite blocks, disabled grooming adaptors, ENT applicators, graduated liquid medication containers, hand splints and components. We offer hemorrhoid cushions, microscope slide more...
Wealthy Best Industrial Ltd | Address: 1/f Block A, Chung Mei Centre, 15 Hing Yip Street, Kwun Tong, Kowloon, Hong Kong, China
Phone: +86-(852)-23455203
FDA Registration: 3004713344
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), External Limb Component, Ankle/Foot (FDA Code: ISH), Water Circulating Hot/Cold Pack (FDA Code: ILO), ...
Wealthy Best Industrial Ltd manufactures braces. Our products are ankle brace/support, cervical orthosis, knee brace/support, reservoir unit and wrist and hand splints/braces. more...
Phone: +86-(852)-23455203
FDA Registration: 3004713344
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), External Limb Component, Ankle/Foot (FDA Code: ISH), Water Circulating Hot/Cold Pack (FDA Code: ILO), ...
Wealthy Best Industrial Ltd manufactures braces. Our products are ankle brace/support, cervical orthosis, knee brace/support, reservoir unit and wrist and hand splints/braces. more...
Sifang Medical Corporation | Address: No. 501, No. 43 Cangsong Road, Ningbo 315012, China
www.sifangmedical.com | Send Inquiry | Phone: +86-(574)-87844588
FDA Registration: 3003967977
Products: Fetal Stethoscope (FDA Code: HGN), Stethoscope Head (FDA Code: BZS), Manual Stethoscope (FDA Code: LDE), Percussor, Vibrator (FDA Code: GWZ), Otoscopes (FDA Code: ERA), Hand Splint and Component (FDA Code: ILH), ...
Sifang Medical Corporation specializes in production of stethoscopes. Our products include deluxe single head & dual-head stethoscopes, sprague rappaport type stethoscopes, disposable type stethoscope more...
www.sifangmedical.com | Send Inquiry | Phone: +86-(574)-87844588
FDA Registration: 3003967977
Products: Fetal Stethoscope (FDA Code: HGN), Stethoscope Head (FDA Code: BZS), Manual Stethoscope (FDA Code: LDE), Percussor, Vibrator (FDA Code: GWZ), Otoscopes (FDA Code: ERA), Hand Splint and Component (FDA Code: ILH), ...
Sifang Medical Corporation specializes in production of stethoscopes. Our products include deluxe single head & dual-head stethoscopes, sprague rappaport type stethoscopes, disposable type stethoscope more...
Guangzhou Fortunique Ltd. | Address: Block B 2, Zhou Shan Gang, Shi Bei Industrial Ave, Pan Yu Dist., Guangzhou 511410, China
FDA Registration: 3003915904
Products: Ice Bags (FDA Code: KYR), Cast Shoe (FDA Code: IPG), External Non-Inflatable Extremity Splint (FDA Code: FYH), Corrective Shoe Orthosis (FDA Code: KNP), External Brace Component Stirrup (FDA Code: ITC), External Limb Component, Ankle/Foot (FDA Code: ISH), ...
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: Ice Bags (FDA Code: KYR), Cast Shoe (FDA Code: IPG), External Non-Inflatable Extremity Splint (FDA Code: FYH), Corrective Shoe Orthosis (FDA Code: KNP), External Brace Component Stirrup (FDA Code: ITC), External Limb Component, Ankle/Foot (FDA Code: ISH), ...
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...
Planet (hong Kong) International Co., Ltd. | Address: Rm. 805-807, Tong Da Mansion, No.1, Lane 600, Tian Shan Rd, Shanghai 200051, China
planethk.en.alibaba.com | Phone: +86-(21)-61136398
FDA Registration: 3004939558 Year Established: 2004 Employee Count: ~50
Products: Ice Bags (FDA Code: KYR), Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Patient Examination Glove (FDA Code: FMC), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), Skin Protectant Liquid Bandage (FDA Code: NEC), ...
Planet (hong Kong) International Co., Ltd. specializes in producing first aid associated products, and also offer private label programs or OEM service for a wide variety of first aid products. Our pr more...
planethk.en.alibaba.com | Phone: +86-(21)-61136398
FDA Registration: 3004939558 Year Established: 2004 Employee Count: ~50
Products: Ice Bags (FDA Code: KYR), Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Patient Examination Glove (FDA Code: FMC), Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE), Skin Protectant Liquid Bandage (FDA Code: NEC), ...
Planet (hong Kong) International Co., Ltd. specializes in producing first aid associated products, and also offer private label programs or OEM service for a wide variety of first aid products. Our pr more...
Leison medical & healthcare Co., Ltd | Address: 23B Hongshen Tower, No.16, lane 710, Dingxi Road, Shanghai 200052, China
www.leisonmedical.com | Send Inquiry | Phone: +86-(21)-68099884
Products: Cervical Collars, Arm Slings (FDA Code: ILI), Economy Knee Immobilizer, Adjustable Plastic Collar with Chin, Adjustable Plastic Collar, Clavicle Supports, ...
Leison medical & healthcare Co., Ltd provides products and services in the field of orthopedic & rehabilitation. Our product line comprises of cervical collar, clavicle support, arm sling, wrist & elb more...
www.leisonmedical.com | Send Inquiry | Phone: +86-(21)-68099884
Products: Cervical Collars, Arm Slings (FDA Code: ILI), Economy Knee Immobilizer, Adjustable Plastic Collar with Chin, Adjustable Plastic Collar, Clavicle Supports, ...
Leison medical & healthcare Co., Ltd provides products and services in the field of orthopedic & rehabilitation. Our product line comprises of cervical collar, clavicle support, arm sling, wrist & elb 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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