Limb Cover Suppliers
Limit companies to: Worldwide USA
Tamarack Habilitation Technologies, Inc. | Address: 1670 94th Lane NE, Blaine, Minnesota 55449, USA 
www.oandp.com/tamarack | Send Inquiry | Phone: +1-(763)-795-0057
FDA Registration: 2133465 Year Established: 1990 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Wheelchair Accessories (FDA Code: KNO), Wheelchair Accessories, Anti Fold Device, Wheelchair Accessories, Amputee Axle Kit, Wheelchair Accessories, Anti-Theft Device, Wheelchair Accessories, Anti-Fold/Anti-Theft Device, Wheelchair Accessories, Amputee Axle Plate, ...
Tamarack Habilitation Technologies, Inc. specializes in ankle-foot biomechanics and friction management technologies and provides orthotic and prosthetic products. We develop the Tamarack, a line of f more...
www.oandp.com/tamarack | Send Inquiry | Phone: +1-(763)-795-0057
FDA Registration: 2133465 Year Established: 1990 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Wheelchair Accessories (FDA Code: KNO), Wheelchair Accessories, Anti Fold Device, Wheelchair Accessories, Amputee Axle Kit, Wheelchair Accessories, Anti-Theft Device, Wheelchair Accessories, Anti-Fold/Anti-Theft Device, Wheelchair Accessories, Amputee Axle Plate, ...
Tamarack Habilitation Technologies, Inc. specializes in ankle-foot biomechanics and friction management technologies and provides orthotic and prosthetic products. We develop the Tamarack, a line of f more...
Osborn Medical Corp. | Address: 100 West Main, PO Box 324, Utica, Minnesota 55979, USA
osbornmedical.com | Send Inquiry | Phone: +1-(507)-932-5028, 800-535-5865
FDA Registration: 2184046 Year Established: 1987 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: 3-Panel Knee Immobilizer, Knee Immobilizer, Felt-Lined Knee Immobilizer, Economy Knee Immobilizer, Hydraulic Photo-Electric Plethysmograph (FDA Code: JOM), Limb Brace Orthosis (FDA Code: IQI), ...
Osborn Medical Corp. specializes in optimal vascular health. We design products in the diagnosis, care and treatment of circulatory conditions. Our Rooke® boot is designed to provide optimal insul more...
osbornmedical.com | Send Inquiry | Phone: +1-(507)-932-5028, 800-535-5865
FDA Registration: 2184046 Year Established: 1987 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: ISO, CE Certified
Products: 3-Panel Knee Immobilizer, Knee Immobilizer, Felt-Lined Knee Immobilizer, Economy Knee Immobilizer, Hydraulic Photo-Electric Plethysmograph (FDA Code: JOM), Limb Brace Orthosis (FDA Code: IQI), ...
Osborn Medical Corp. specializes in optimal vascular health. We design products in the diagnosis, care and treatment of circulatory conditions. Our Rooke® boot is designed to provide optimal insul more...
Compression Therapy Concepts, Inc. | Address: 35 James Way, Eatontown, New Jersey 07724, USA
www.ctcdvt.com | Send Inquiry | Phone: +1-(800)-993-9013
FDA Registration: 2249552 Year Established: 1999 Annual Revenues: USD 1-5 Million Quality: ISO, CE Certified
Products: Protective Mitt, Limb Cover (FDA Code: IPM), Bariatric Calf Garments, Thigh Garments, Bariatric Thigh Garments, Foot Garments, ...
Compression Therapy Concepts, Inc. is associated with non-invasive approach to deep vein thrombosis (DVT) prophylaxis. Our VasoPress® DVT system prevents deep vein thrombosis and concomitant pulmo more...
www.ctcdvt.com | Send Inquiry | Phone: +1-(800)-993-9013
FDA Registration: 2249552 Year Established: 1999 Annual Revenues: USD 1-5 Million Quality: ISO, CE Certified
Products: Protective Mitt, Limb Cover (FDA Code: IPM), Bariatric Calf Garments, Thigh Garments, Bariatric Thigh Garments, Foot Garments, ...
Compression Therapy Concepts, Inc. is associated with non-invasive approach to deep vein thrombosis (DVT) prophylaxis. Our VasoPress® DVT system prevents deep vein thrombosis and concomitant pulmo more...
Synthes (USA) | Address: 35 Airport Road, Horseheads, New York 14845, USA
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
www.synthes.com/html | Send Inquiry | Phone: +1-(610)-719-5000
FDA Registration: 3003506883 Year Established: 1974 Annual Revenues: > USD 1 Billion Employee Count: ~9000
Products: Bone Taps (FDA Code: HWX), Stainless Steel Surgical Wire, Drill Bits & Bone Taps, Surgical Wire (FDA Code: LRN), Burr Hole Cover (FDA Code: GXR), Bone Fixation Plate (FDA Code: HRS), ...
Synthes (USA) is a medical device company. We develop, produce and market instruments, implants & biomaterials for the surgical fixation, correction and regeneration of the human skeleton & its soft t more...
Pillet Hand Prostheses Ltd | Address: 331 West 57th St, PMB 109, New York, New York 10019, USA
www.pillet.com | Send Inquiry | Phone: +1-(212)-307-0927/800-331-4263
FDA Registration: 3008485437
Products: Upper Limb Prostheses Components, Prosthetics, Upper Limb, Hand Prosthetics, Limb Cover (FDA Code: IPM), ...
Pillet Hand Prostheses Ltd focuses on aesthetics prostheses. We specialize in aesthetic prosthesis with passive function for adults as well as children. more...
www.pillet.com | Send Inquiry | Phone: +1-(212)-307-0927/800-331-4263
FDA Registration: 3008485437
Products: Upper Limb Prostheses Components, Prosthetics, Upper Limb, Hand Prosthetics, Limb Cover (FDA Code: IPM), ...
Pillet Hand Prostheses Ltd focuses on aesthetics prostheses. We specialize in aesthetic prosthesis with passive function for adults as well as children. more...
Rx Textiles | Address: 3107 Chamber Dr., Monroe, North Carolina 28110, USA
www.rxtextiles.com | Send Inquiry | Phone: +1-(704)-283-9787
FDA Registration: 1061153
Products: Elastic Tubular Bandages, Cotton Stockinette, Synthetic Stockinette, Medical Fabrics Products, Fracture Sock, Stockinette, ...
Rx Textiles specializes in tubular medical fabrics. We offer fracture socks, stockinettes, and tubular elastic bandages. Our cotton/Lycra® sock with a hole at the distal end is specifically design more...
www.rxtextiles.com | Send Inquiry | Phone: +1-(704)-283-9787
FDA Registration: 1061153
Products: Elastic Tubular Bandages, Cotton Stockinette, Synthetic Stockinette, Medical Fabrics Products, Fracture Sock, Stockinette, ...
Rx Textiles specializes in tubular medical fabrics. We offer fracture socks, stockinettes, and tubular elastic bandages. Our cotton/Lycra® sock with a hole at the distal end is specifically design more...
Medi Mfg., Inc. | Address: 6481 Franz Warner Pkwy., Whitsett, North Carolina 27377, USA
www.mediusa.com | Phone: +1-(336)-449-4440
FDA Registration: 1063312 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~160 Quality: ISO 9000, CE Certified
Products: Ankle Braces, Arm Support Extender:, Arm Supports (FDA Code: IOY), Ankle Support, Compressible Limb Sleeve (FDA Code: JOW), External Ankle Brace (FDA Code: ITW), ...
Medi Mfg., Inc. specializes in offering compression therapy products for the treatment and prevention of venous diseases & deep vein thrombosis, as well as the effective management of lymphedema, lipo more...
www.mediusa.com | Phone: +1-(336)-449-4440
FDA Registration: 1063312 Year Established: 1984 Annual Revenues: USD 10-25 Million Employee Count: ~160 Quality: ISO 9000, CE Certified
Products: Ankle Braces, Arm Support Extender:, Arm Supports (FDA Code: IOY), Ankle Support, Compressible Limb Sleeve (FDA Code: JOW), External Ankle Brace (FDA Code: ITW), ...
Medi Mfg., Inc. specializes in offering compression therapy products for the treatment and prevention of venous diseases & deep vein thrombosis, as well as the effective management of lymphedema, lipo more...
Endolite North America, Ltd. | Address: 105 Westpark Rd., Centerville, Ohio 45459, USA
www.endolite.com | Send Inquiry | Phone: +1-(937)-291-3636, 800.548.3534
FDA Registration: 1058311
Products: Medical Support Stocking (FDA Code: FQL), External Limb Component, Ankle/Foot (FDA Code: ISH), External Limb Component Hip Joint (FDA Code: ISL), External Limb Component Knee Joint (FDA Code: ISY), Limb Cover (FDA Code: IPM), Latex Cones, ...
Endolite North America, Ltd. produces artificial limbs and prosthetic components. We focus on the use of carbon fiber composite materials and smart electronics to provide sophisticated yet practical s more...
www.endolite.com | Send Inquiry | Phone: +1-(937)-291-3636, 800.548.3534
FDA Registration: 1058311
Products: Medical Support Stocking (FDA Code: FQL), External Limb Component, Ankle/Foot (FDA Code: ISH), External Limb Component Hip Joint (FDA Code: ISL), External Limb Component Knee Joint (FDA Code: ISY), Limb Cover (FDA Code: IPM), Latex Cones, ...
Endolite North America, Ltd. produces artificial limbs and prosthetic components. We focus on the use of carbon fiber composite materials and smart electronics to provide sophisticated yet practical s more...
Acor Orthopaedic Inc | Address: 18530 S Miles Pkwy, Cleveland, Ohio 44128, USA
www.acor.com | Send Inquiry | Phone: +1-(216)-662-4500
FDA Registration: 1527888 Annual Revenues: USD 5-10 Million
Products: Foot Orthotics, Medical Insoles (FDA Code: KYS), Custom Prosthesis, Orthopedic Fixation Accessories (FDA Code: LYT), Orthopedic Shoe (Clothing, Aid, Foot, Prosthesis, Walk), Corrective Shoe Orthosis (FDA Code: KNP), ...
Acor Orthopaedic Inc produces custom footwear products for practitioners and patients. We provide prosthetic and orthotic & pedorthic devices to industries who manufacture foot care products. We distr more...
www.acor.com | Send Inquiry | Phone: +1-(216)-662-4500
FDA Registration: 1527888 Annual Revenues: USD 5-10 Million
Products: Foot Orthotics, Medical Insoles (FDA Code: KYS), Custom Prosthesis, Orthopedic Fixation Accessories (FDA Code: LYT), Orthopedic Shoe (Clothing, Aid, Foot, Prosthesis, Walk), Corrective Shoe Orthosis (FDA Code: KNP), ...
Acor Orthopaedic Inc produces custom footwear products for practitioners and patients. We provide prosthetic and orthotic & pedorthic devices to industries who manufacture foot care products. We distr more...
Juzo | Address: 80 Chart Road, PO Box 1088, Cuyahoga Falls, Ohio 44223-0088, USA
www.juzousa.com | Send Inquiry | Phone: +1-(330)-923-4999, 800-222-4999
FDA Registration: 1527846 Year Established: 1912 Annual Revenues: USD 5-10 Million Employee Count: ~80
Products: Arm Supports (FDA Code: IOY), Apron Sleeve, Elastic Knee Sleeve, Calf Sleeve, Limb Brace Orthosis (FDA Code: IQI), Limb Cover (FDA Code: IPM), ...
Juzo provides elastic support stump shrinker and suspension sleeves. Our socks offer a stylish alternative to traditional compression therapy socks while still providing the necessary support for indi more...
www.juzousa.com | Send Inquiry | Phone: +1-(330)-923-4999, 800-222-4999
FDA Registration: 1527846 Year Established: 1912 Annual Revenues: USD 5-10 Million Employee Count: ~80
Products: Arm Supports (FDA Code: IOY), Apron Sleeve, Elastic Knee Sleeve, Calf Sleeve, Limb Brace Orthosis (FDA Code: IQI), Limb Cover (FDA Code: IPM), ...
Juzo provides elastic support stump shrinker and suspension sleeves. Our socks offer a stylish alternative to traditional compression therapy socks while still providing the necessary support for indi more...
Ohio Willow Wood | Address: 15441 Scioto Darby Rd, PO Box 130, Mount Sterling, Ohio 43143, USA
www.owwco.com | Send Inquiry | Phone: +1-(740)-869-3377/800-848-4930
FDA Registration: 1522166 Year Established: 1907 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: CE Certified
Products: Flat Foot Prosthesis Fragment Sets, Leg Prosthesis, Foot Prosthesis, Lower Extremity Prostheses Components, Prosthetic Devices, Prosthetic Liners, ...
Ohio Willow Wood designs and manufactures prosthetics. We provide Alpha® liners & suspensions, OMEGA® Tracer CAD, prosthetics feet and endoskeleton components. OMEGA® Tracer CAD provides s more...
www.owwco.com | Send Inquiry | Phone: +1-(740)-869-3377/800-848-4930
FDA Registration: 1522166 Year Established: 1907 Annual Revenues: USD 10-25 Million Employee Count: ~140 Quality: CE Certified
Products: Flat Foot Prosthesis Fragment Sets, Leg Prosthesis, Foot Prosthesis, Lower Extremity Prostheses Components, Prosthetic Devices, Prosthetic Liners, ...
Ohio Willow Wood designs and manufactures prosthetics. We provide Alpha® liners & suspensions, OMEGA® Tracer CAD, prosthetics feet and endoskeleton components. OMEGA® Tracer CAD provides s more...
Circulator Boot Corp. | Address: 72 Pennsylvania Avenue, Malvern, Pennsylvania 19355, USA
www.circulatorboot.com | Send Inquiry | Phone: +1-(610)-240-9980
Annual Revenues: < USD 1 Million
Products: Compressible Limb Sleeve (FDA Code: JOW), External Counterpulsating Pump (FDA Code: DRN), Compression Instrument (FDA Code: HWN), Limb Cover (FDA Code: IPM), ...
Circulator Boot Corp. is associated with cardio-based compression therapy. We specialize in Circulator Boot™, a device that benefits heart function, and arterial, venous and lymphatic circulatio more...
www.circulatorboot.com | Send Inquiry | Phone: +1-(610)-240-9980
Annual Revenues: < USD 1 Million
Products: Compressible Limb Sleeve (FDA Code: JOW), External Counterpulsating Pump (FDA Code: DRN), Compression Instrument (FDA Code: HWN), Limb Cover (FDA Code: IPM), ...
Circulator Boot Corp. is associated with cardio-based compression therapy. We specialize in Circulator Boot™, a device that benefits heart function, and arterial, venous and lymphatic circulatio more...
Health Related Products, Inc. | Address: P.O.Box No. 3465, Greenwood, South Carolina 29649, USA
www.hrp.greenwood.net | Send Inquiry | Phone: +1-(864)-229-1262, 800-845-4566
Products: Allergy Syringes/Trays, Adhesive Bandages (FDA Code: KGX), Adult Reusable Incontinence Pads, Adult Disposable Incontinence Pads, Antimicrobial Barrier Dressing, Anti-Embolism Stockings, ...
Health Related Products, Inc. is a distributor of adult incontinence, wound care, and accessory products. Realastic® production coverings are available in two styles including vinyl and silicone. more...
www.hrp.greenwood.net | Send Inquiry | Phone: +1-(864)-229-1262, 800-845-4566
Products: Allergy Syringes/Trays, Adhesive Bandages (FDA Code: KGX), Adult Reusable Incontinence Pads, Adult Disposable Incontinence Pads, Antimicrobial Barrier Dressing, Anti-Embolism Stockings, ...
Health Related Products, Inc. is a distributor of adult incontinence, wound care, and accessory products. Realastic® production coverings are available in two styles including vinyl and silicone. more...
Chattanooga Group | Address: 4717 Adams Road, Hixson, Tennessee 37343, USA
www.chattgroup.com | Phone: +1-(423)-870.2281, 800.592.7329
Year Established: 1947 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Carts, Chairs & stools, Compression Garments, Cryosurgery, EKG Supplies, Exam Tables, ...
Chattanooga Group produces rehabilitation equipment for treating skeletal, muscular, neurological and soft tissue disorders. Our laser therapy uses light to penetrate tissue for increased blood flow a more...
www.chattgroup.com | Phone: +1-(423)-870.2281, 800.592.7329
Year Established: 1947 Annual Revenues: USD 50-100 Million Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Carts, Chairs & stools, Compression Garments, Cryosurgery, EKG Supplies, Exam Tables, ...
Chattanooga Group produces rehabilitation equipment for treating skeletal, muscular, neurological and soft tissue disorders. Our laser therapy uses light to penetrate tissue for increased blood flow a more...
Debusk Orthopedic Casting (doc) | Address: 420 Straight Creek Road, Suite 1, New Tazewell, Tennessee 37825, USA
Phone: +1-(865)-362-2334
Products: Adhesive Elastic Bandage Tape, Cohesive Elastic Bandage, Cohesive Elastic Bandage Wrap, Elastic Bandage with Removable Clip, Cast Component (FDA Code: LGF), Cast Bandage (FDA Code: ITG), ...
Debusk Orthopedic Casting (doc) provides splinting material and walkers cold therapy units and blankets non-sterile stockinette powered cast saw, fiberglass casting tape, plasters, elastic bandage, ca more...
Phone: +1-(865)-362-2334
Products: Adhesive Elastic Bandage Tape, Cohesive Elastic Bandage, Cohesive Elastic Bandage Wrap, Elastic Bandage with Removable Clip, Cast Component (FDA Code: LGF), Cast Bandage (FDA Code: ITG), ...
Debusk Orthopedic Casting (doc) provides splinting material and walkers cold therapy units and blankets non-sterile stockinette powered cast saw, fiberglass casting tape, plasters, elastic bandage, ca more...
Royal Converting, Inc. | Address: 1615 Hwy. 33 South, New Tazewell, Tennessee 37825, USA
Phone: +1-(865)-938-7828
Products: Wheelchairs, Wheelchair Cushions, Hydrophilic Wound Dressings (FDA Code: NAC), Patient Position Support (FDA Code: CCX), Hydrogel Wound and Burn Dressing (FDA Code: MGQ), Occlusive Wound Dressing (FDA Code: NAD), ...
Royal Converting, Inc. offers hydrogel wound & burn dressings, hydrophilic wound dressings, occlusive wound dressings, patient positioners, skin pressure protectors and wheelchair cushions. more...
Phone: +1-(865)-938-7828
Products: Wheelchairs, Wheelchair Cushions, Hydrophilic Wound Dressings (FDA Code: NAC), Patient Position Support (FDA Code: CCX), Hydrogel Wound and Burn Dressing (FDA Code: MGQ), Occlusive Wound Dressing (FDA Code: NAD), ...
Royal Converting, Inc. offers hydrogel wound & burn dressings, hydrophilic wound dressings, occlusive wound dressings, patient positioners, skin pressure protectors and wheelchair cushions. more...
Border Opportunity Saver Systems | Address: 10 Finegan Drive, Del Rio, Texas 78841, USA
www.borderopp.com | Send Inquiry | Phone: +1-(830)-775-1225
FDA Registration: 1640425 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~420 Quality: ISO Certified
Products: Packaging, Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Wound Dressing Kit (FDA Code: MCY), Contract Manufacturing, Patient Restraint Stretcher (FDA Code: NZD), ...
Border Opportunity Saver Systems deals with high quality, low cost contract manufacturing and packaging. more...
www.borderopp.com | Send Inquiry | Phone: +1-(830)-775-1225
FDA Registration: 1640425 Year Established: 1979 Annual Revenues: USD 5-10 Million Employee Count: ~420 Quality: ISO Certified
Products: Packaging, Travel First Aid Kit with Drug (FDA Code: LRR), Emergency First Aid Kit (FDA Code: LRR), Wound Dressing Kit (FDA Code: MCY), Contract Manufacturing, Patient Restraint Stretcher (FDA Code: NZD), ...
Border Opportunity Saver Systems deals with high quality, low cost contract manufacturing and packaging. more...
Kerma Medical Products, Inc. | Address: 400 Port Centre Parkway, Portsmouth, Virginia 23704, USA
www.kermamedical.com | Phone: +1-(757)-398-8400, 800-492-0903
FDA Registration: 1123029
Products: Blood pressure Cuffs (FDA Code: DXQ), Aneroid Sphygmomanometer, Digital Thermometers, Disposable Washcloths, Disposable Face Shields, Dressing Pad, ...
Kerma Medical Products, Inc. offers baby bonnets, digital thermometers, disposable washcloths, elastic bandages, fetal monitor, fillable ice bags, burn dressing, aneroid sphygmomanometers, protective more...
www.kermamedical.com | Phone: +1-(757)-398-8400, 800-492-0903
FDA Registration: 1123029
Products: Blood pressure Cuffs (FDA Code: DXQ), Aneroid Sphygmomanometer, Digital Thermometers, Disposable Washcloths, Disposable Face Shields, Dressing Pad, ...
Kerma Medical Products, Inc. offers baby bonnets, digital thermometers, disposable washcloths, elastic bandages, fetal monitor, fillable ice bags, burn dressing, aneroid sphygmomanometers, protective more...
Foot Levelers Inc. | Address: PO Box 12611, Roanoke, Virginia 24027-2611, USA
www.footlevelers.com | Send Inquiry | Phone: +1-(540)-345-0008
FDA Registration: 1911617
Products: Insoles & Footwear, Pillows & Cushions, Orthotics Insoles, Orthopedic Insoles, Rolls & Pillows, Runners Insoles, ...
Foot Levelers Inc. markets custom-made, flexible spinal pelvic stabilizers, sandalthotics and shoethotics to healthcare professionals. We also offer a wide selection of cervical support pillows, rehab more...
www.footlevelers.com | Send Inquiry | Phone: +1-(540)-345-0008
FDA Registration: 1911617
Products: Insoles & Footwear, Pillows & Cushions, Orthotics Insoles, Orthopedic Insoles, Rolls & Pillows, Runners Insoles, ...
Foot Levelers Inc. markets custom-made, flexible spinal pelvic stabilizers, sandalthotics and shoethotics to healthcare professionals. We also offer a wide selection of cervical support pillows, rehab more...
ABC Health Solutions | Address: 14008 SE 238th Ln, Kent, Washington 98042, USA
www.abchealthsolutions.biz | Phone: +1-(253)-631-8270
Products: Protective Mitt, Limb Cover (FDA Code: IPM), Custom Wraps & Blankets, Elbow & Knee Wraps, Cummerbunds, Tendinitis Gloves, ...
ABC Health Solutions specializes in therapeutic products utilizing the Farabloc technology. We offer limb covers, tendinitis gloves, socks, elbow & knee wraps and belts for lower back. more...
www.abchealthsolutions.biz | Phone: +1-(253)-631-8270
Products: Protective Mitt, Limb Cover (FDA Code: IPM), Custom Wraps & Blankets, Elbow & Knee Wraps, Cummerbunds, Tendinitis Gloves, ...
ABC Health Solutions specializes in therapeutic products utilizing the Farabloc technology. We offer limb covers, tendinitis gloves, socks, elbow & knee wraps and belts for lower back. more...
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FDA Code / Regulation: IPM / 890.3025
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
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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