External Ankle Brace Suppliers
Limit companies to: Worldwide USA
Pro Orthopedic Devices | Address: 2884 East Ganley Road, Tucson, Arizona 85706, USA 
www.proorthopedic.com | Send Inquiry | Phone: +001-(523)-523-5611
FDA Registration: 3000944672 Year Established: 1994 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: CE Certified
Products: Ophthalmoscopes, Scissors, Direct Ophthalmoscopes, Phacoemulsification Systems, MVR Blades, OptoKinetic Nystagmus Drum, ...
Pro Orthopedic Devices focuses on sports medicine. We market knee supports, patella stabilizers, hinged braces, ankle supports, calf supports, elbow supports, low back supports and scuff pads. In our more...
www.proorthopedic.com | Send Inquiry | Phone: +001-(523)-523-5611
FDA Registration: 3000944672 Year Established: 1994 Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: CE Certified
Products: Ophthalmoscopes, Scissors, Direct Ophthalmoscopes, Phacoemulsification Systems, MVR Blades, OptoKinetic Nystagmus Drum, ...
Pro Orthopedic Devices focuses on sports medicine. We market knee supports, patella stabilizers, hinged braces, ankle supports, calf supports, elbow supports, low back supports and scuff pads. In our more...
Ita-med Co | Address: 25377 Huntwood Ave., Hayward, California 94544, USA
www.itamed.com | Send Inquiry | Phone: +1-(650)-873-7900
Products: Splints, Back Braces & Supports, Hip Supports, Knee/Ankle Braces & Supports, Rib & Abdomen Supports, Thumb & Elbow Brace & Supports, ...
Ita-med Co is a manufacturer of medical support products for home and personal use. Our product line comprises of gabrialla compression hosiery & maternity and woman's health collections, back, abdomi more...
www.itamed.com | Send Inquiry | Phone: +1-(650)-873-7900
Products: Splints, Back Braces & Supports, Hip Supports, Knee/Ankle Braces & Supports, Rib & Abdomen Supports, Thumb & Elbow Brace & Supports, ...
Ita-med Co is a manufacturer of medical support products for home and personal use. Our product line comprises of gabrialla compression hosiery & maternity and woman's health collections, back, abdomi more...
VQ OrthoCare | Address: 18011 Mitchell South, Irvine, California 92614-6007, USA
www.vqorthocare.com/orders | Send Inquiry | Phone: (800) 652-1135
FDA Registration: 2031823
Products: Knee Braces, Hand and Wrist Braces, Skin Closures, Knee Braces, Exercise Therapy kits, Orthopedic knee Braces, Adult Hand & Wrist Splints, ...
Vq OrthoCARE Wholesale offers caring services and supports orthopedic rehabilitation & surgical needs. We provide unparalleled patient support with patient care representatives and DME orthopedic tech more...
www.vqorthocare.com/orders | Send Inquiry | Phone: (800) 652-1135
FDA Registration: 2031823
Products: Knee Braces, Hand and Wrist Braces, Skin Closures, Knee Braces, Exercise Therapy kits, Orthopedic knee Braces, Adult Hand & Wrist Splints, ...
Vq OrthoCARE Wholesale offers caring services and supports orthopedic rehabilitation & surgical needs. We provide unparalleled patient support with patient care representatives and DME orthopedic tech more...
Orthomerica Products, Inc. | Address: #505, 31st Street, Newport Beach, California 92663, USA
www.orthomerica.com | Send Inquiry | Phone: +1-(949)-723-4500
FDA Registration: 1058152 Year Established: 1989 Annual Revenues: USD 10-25 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Acetabular Liners, Hip Orthoses, Pediatric Orthoses, Cervicothoracic Lumbar Orthosis, Prefabricated Hip Orthoses, Bilateral Hip Orthoses, ...
Orthomerica Products, Inc. manufactures and markets prefabricated, semi-custom & custom orthoses. We are an ISO 9001, CE MARK certified company. We offer products like hip orthoses, low extremity orth more...
www.orthomerica.com | Send Inquiry | Phone: +1-(949)-723-4500
FDA Registration: 1058152 Year Established: 1989 Annual Revenues: USD 10-25 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Acetabular Liners, Hip Orthoses, Pediatric Orthoses, Cervicothoracic Lumbar Orthosis, Prefabricated Hip Orthoses, Bilateral Hip Orthoses, ...
Orthomerica Products, Inc. manufactures and markets prefabricated, semi-custom & custom orthoses. We are an ISO 9001, CE MARK certified company. We offer products like hip orthoses, low extremity orth more...
Mizuho OSI | Address: 30031 Ahern Avenue, Union City, California 94587-1234, USA
www.osiosi.com | Send Inquiry | Phone: +1-(510)-429-1500, 800-777-4674
FDA Registration: 2921578 Year Established: 1978 Annual Revenues: USD 50-100 Million Employee Count: ~270 Quality: ISO 9001, CE Certified
Products: Radiolucent Spinal Frame, Fracture Tables, Casting Stands, General Medical Supplies, Elastic Bandages (FDA Code: FQM), Casting Materials and Equipment, Casting Stands, ...
Mizuho OSI designs & manufactures medical products. Our products include surgical tables, table accessories, traction systems, pressure management, and hand surgery. Our Advanced Control Pad System&tr more...
www.osiosi.com | Send Inquiry | Phone: +1-(510)-429-1500, 800-777-4674
FDA Registration: 2921578 Year Established: 1978 Annual Revenues: USD 50-100 Million Employee Count: ~270 Quality: ISO 9001, CE Certified
Products: Radiolucent Spinal Frame, Fracture Tables, Casting Stands, General Medical Supplies, Elastic Bandages (FDA Code: FQM), Casting Materials and Equipment, Casting Stands, ...
Mizuho OSI designs & manufactures medical products. Our products include surgical tables, table accessories, traction systems, pressure management, and hand surgery. Our Advanced Control Pad System&tr more...
DME-Direct Inc. | Address: 28910 Avenue Penn, Suite 207, Valencia, California 91355, USA
www.dme-direct.com | Send Inquiry | Phone: +1-(661)-705-8330
Products: Ankle Braces, Knee/Ankle Braces & Supports, Flexible Ankle Braces, Adult Hand & Wrist Splints, Neoprene Ankle Sleeve, Shoulder Abduction Splint, ...
DME-Direct Inc. is a distributor of orthopedic bracing, and wound care products. Our products include ankle braces, orthopedic back braces, knee braces & sleeves, forearm splints, and elastic wrist su more...
www.dme-direct.com | Send Inquiry | Phone: +1-(661)-705-8330
Products: Ankle Braces, Knee/Ankle Braces & Supports, Flexible Ankle Braces, Adult Hand & Wrist Splints, Neoprene Ankle Sleeve, Shoulder Abduction Splint, ...
DME-Direct Inc. is a distributor of orthopedic bracing, and wound care products. Our products include ankle braces, orthopedic back braces, knee braces & sleeves, forearm splints, and elastic wrist su more...
DJ Orthopedics Inc. | Address: 2985 Scott Street, Vista, California 92081, USA
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, Forceps (FDA Code: HTD), External Bone Growth Stimulators, Bone Rasps (FDA Code: HTR), Surgical Helmet Systems, Ankle Braces, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b more...
www.djortho.com | Phone: +1-(760)-727-1280, (800)-321-9549
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Splints, Forceps (FDA Code: HTD), External Bone Growth Stimulators, Bone Rasps (FDA Code: HTR), Surgical Helmet Systems, Ankle Braces, ...
DJ Orthopedics, Inc. is a global medical device company specializing in rehabilitation and regeneration products for the non-operative orthopedic & spine markets. We offer products like ankle & knee b more...
Maramed Orthopedic Systems | Address: 2480 West 82nd Street, #8, Hialeah, Florida 33016, USA
www.maramed.com | Send Inquiry | Phone: +1-(305)-823-8300, (800)-327-5830
Year Established: 1973 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Orthopedic Cushions, Humeral Splints, Hip Orthoses, Prefabricated Hip Orthoses, Bilateral Hip Orthoses, Unilateral Hip Orthoses, ...
Maramed Orthopedic Systems manufactures and supplies prefabricated orthopedic braces. We concentrate in orthoses and fracture braces. We offer products like upper extremity fracture braces, elbow, ank more...
www.maramed.com | Send Inquiry | Phone: +1-(305)-823-8300, (800)-327-5830
Year Established: 1973 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Orthopedic Cushions, Humeral Splints, Hip Orthoses, Prefabricated Hip Orthoses, Bilateral Hip Orthoses, Unilateral Hip Orthoses, ...
Maramed Orthopedic Systems manufactures and supplies prefabricated orthopedic braces. We concentrate in orthoses and fracture braces. We offer products like upper extremity fracture braces, elbow, ank more...
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Restorative Care of America, Inc. | Address: 12221 33rd Street North, St. Petersburg, Florida 33716, USA
www.rcai.com | Send Inquiry | Phone: +1-(727)-573-1595, (800)-627-1595
FDA Registration: 1051118 Year Established: 1975 Annual Revenues: USD 5-10 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Splints, Hip Orthoses, Pediatric Orthoses, Orthoses Cervico-Thoracic Braces, Head Cervicothoracic Orthoses, Orthoses, Foot Braces, ...
Restorative Care of America, Inc. manufactures orthopedic and rehabilitative orthoses used in the treatment of conditions associated with traumatic injuries, chronic disease, post surgical procedures, more...
www.rcai.com | Send Inquiry | Phone: +1-(727)-573-1595, (800)-627-1595
FDA Registration: 1051118 Year Established: 1975 Annual Revenues: USD 5-10 Million Employee Count: ~90 Quality: ISO 9001, CE Certified
Products: Splints, Hip Orthoses, Pediatric Orthoses, Orthoses Cervico-Thoracic Braces, Head Cervicothoracic Orthoses, Orthoses, Foot Braces, ...
Restorative Care of America, Inc. manufactures orthopedic and rehabilitative orthoses used in the treatment of conditions associated with traumatic injuries, chronic disease, post surgical procedures, more...
Sky Medical, Inc. | Address: 5229 NW 108 Ave, Sunrise, Florida 33351, USA
www.skymedicalinc.com | Send Inquiry | Phone: +1-(954)-747-3188
FDA Registration: 1062863
Products: Ankle Braces, Elbow Braces, Foot Braces, Humeral Splints, Hand and Wrist Braces, Thumb Splints, ...
Sky Medical, Inc. manufactures clinically designed fracture braces, hand & foot immobilizers and upper & lower extremity orthotics. Our thumb spika orthosis is a lightweight orthosis designed to comfo more...
www.skymedicalinc.com | Send Inquiry | Phone: +1-(954)-747-3188
FDA Registration: 1062863
Products: Ankle Braces, Elbow Braces, Foot Braces, Humeral Splints, Hand and Wrist Braces, Thumb Splints, ...
Sky Medical, Inc. manufactures clinically designed fracture braces, hand & foot immobilizers and upper & lower extremity orthotics. Our thumb spika orthosis is a lightweight orthosis designed to comfo more...
Bauerfeind USA, Inc. | Address: 55 Chastain Road, Suite 112, Kennesaw, Georgia 30144, USA
www.bauerfeindusa.com | Send Inquiry | Phone: +1-(800)-423-3405
FDA Registration: 1037964 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Foot Braces, Shoulder Braces, Knee Braces, Hand and Wrist Braces, ...
Bauerfeind USA, Inc. manufactures medical aids. We focus on orthopedics and phlebology products. We offer doctors and medical retailer's sophisticated concepts for the individual treatment of conditio more...
www.bauerfeindusa.com | Send Inquiry | Phone: +1-(800)-423-3405
FDA Registration: 1037964 Year Established: 1985 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Foot Braces, Shoulder Braces, Knee Braces, Hand and Wrist Braces, ...
Bauerfeind USA, Inc. manufactures medical aids. We focus on orthopedics and phlebology products. We offer doctors and medical retailer's sophisticated concepts for the individual treatment of conditio more...
DM Systems, Inc | Address: 1316 Sherman Avenue, Evanston, Illinois 60201, USA
www.dmsystems.com | Send Inquiry | Phone: +1-(800)-254-5438
FDA Registration: 1424774 Year Established: 1979 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Foot Braces, Knee Braces, Hand and Wrist Braces, Walkers, ...
DM Systems, Inc is a manufacturer & distributor of wound care, casting, resistive exercise and rehabilitation products. We also supply sports medicine equipment. Our heelift traction boot provides an more...
www.dmsystems.com | Send Inquiry | Phone: +1-(800)-254-5438
FDA Registration: 1424774 Year Established: 1979 Annual Revenues: USD 1-5 Million Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Foot Braces, Knee Braces, Hand and Wrist Braces, Walkers, ...
DM Systems, Inc is a manufacturer & distributor of wound care, casting, resistive exercise and rehabilitation products. We also supply sports medicine equipment. Our heelift traction boot provides an more...
Biomet, Inc | Address: PO Box 587, Warsaw, Indiana 46581-0587, USA
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
www.biomet.com/orthopedics | Send Inquiry | Phone: +1-(574)-267-6639
FDA Registration: 1825034 Year Established: 1977 Annual Revenues: > USD 1 Billion Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Heat or Cold Packs, Blades, Drills, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), ...
Biomet, Inc designs and manufactures products for hip replacement, knee replacement, shoulder replacement, elbow replacement & other small joint replacements. We are an ISO 9001 CE certified company. more...
Zimmer, Inc. | Address: P.O. Box 708 ,1800 West Center Street, Warsaw, Indiana 46581-0708, USA
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
www.zimmer.com | Phone: +1-(574)-372-4790, 800-613-6131
FDA Registration: 1822565 Year Established: 1927 Annual Revenues: > USD 1 Billion Employee Count: ~7600 Quality: ISO 9001, CE Certified
Products: Splints, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Spreaders, Silicone Tubing, Dressing Forceps, ...
Zimmer, Inc. manufactures orthopedic products and instruments. We specialize in joint replacement solutions for knee pain & hip pain. We deliver comprehensive spine care solutions for acute and chroni more...
Brown Medical Industries | Address: 1300 Lundberg Drive West, Spirit Lake, Iowa 51360-7246, USA
www.brownmed.com | Send Inquiry | Phone: +1-(712)-336-4395, 800-843-4395
FDA Registration: 1926174 Year Established: 1965 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Orthopedic Cushions, Splints, Ankle Braces, Elbow Braces, Foot Braces, Knee Braces, ...
Brown Medical Industries manufactures orthopedic products. We are accredited with ISO 9001 certification. Our product categories are cast & bandage covers, compression supports, fraction walker, ice t more...
www.brownmed.com | Send Inquiry | Phone: +1-(712)-336-4395, 800-843-4395
FDA Registration: 1926174 Year Established: 1965 Annual Revenues: USD 5-10 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Orthopedic Cushions, Splints, Ankle Braces, Elbow Braces, Foot Braces, Knee Braces, ...
Brown Medical Industries manufactures orthopedic products. We are accredited with ISO 9001 certification. Our product categories are cast & bandage covers, compression supports, fraction walker, ice t more...
Tempico, Inc. | Address: 1700 West Church Street, Suite C, Hammond, Louisiana 70401, USA
www.tempico.com | Send Inquiry | Phone: +1-(985)-429-9929, 800-728-9006
FDA Registration: 1721293
Products: Electromedical Biofeedback Devices, Medical Waste Processing System, Rotoclaver System, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), ...
Tempico, Inc. produces & distributes the Rotoclave® medical processing systems to medical waste generators such as hospitals and laboratories. Our Rotoclave® technology offers the opportunity more...
www.tempico.com | Send Inquiry | Phone: +1-(985)-429-9929, 800-728-9006
FDA Registration: 1721293
Products: Electromedical Biofeedback Devices, Medical Waste Processing System, Rotoclaver System, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), ...
Tempico, Inc. produces & distributes the Rotoclave® medical processing systems to medical waste generators such as hospitals and laboratories. Our Rotoclave® technology offers the opportunity more...
Boston Brace International | Address: 20 Ledin Drive, Avon, Massachusetts 02322, USA
www.bostonbrace.com | Send Inquiry | Phone: +1-(508)-588-6060, (800)-262-2235
FDA Registration: 3001967835 Year Established: 1952 Annual Revenues: < USD 1 Million Employee Count: ~40
Products: Shoulder Braces, Hip Orthoses, Lumbosacral Braces, Straps, Slings & Immobilizers, Wrist/Arm/Shoulder Braces & Supports, Orthopedic Back Braces, ...
Boston Brace International, Inc. designs and manufactures medical & sports bracing products for prevention, rehabilitation & correction. We offer products such as scoliosis, boston band, dynamic movem more...
www.bostonbrace.com | Send Inquiry | Phone: +1-(508)-588-6060, (800)-262-2235
FDA Registration: 3001967835 Year Established: 1952 Annual Revenues: < USD 1 Million Employee Count: ~40
Products: Shoulder Braces, Hip Orthoses, Lumbosacral Braces, Straps, Slings & Immobilizers, Wrist/Arm/Shoulder Braces & Supports, Orthopedic Back Braces, ...
Boston Brace International, Inc. designs and manufactures medical & sports bracing products for prevention, rehabilitation & correction. We offer products such as scoliosis, boston band, dynamic movem more...
Alimed, Inc. | Address: 297 High Street, Dedham, Massachusetts 02026, USA
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Masks & Breathing Bags, Hypodermic Syringes, Bodyfat Analyzers, Spirometers, Disposable Examination Gloves, Furniture & Storage, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo more...
www.alimed.com | Send Inquiry | Phone: +001-(800)-225-2610
FDA Registration: 1218386 Employee Count: ~180 Quality: ISO, CE Certified
Products: Masks & Breathing Bags, Hypodermic Syringes, Bodyfat Analyzers, Spirometers, Disposable Examination Gloves, Furniture & Storage, ...
Alimed, Inc. is a manufacturer and supplier of pre-formed orthoses, alarms for fall management, cushions, diagnostic imaging & operating room accessories, orthopedic rehabilitation equipment, and ergo more...
Becker Orthopedic | Address: 635 Executive Drive, Troy, Michigan 48083-4576, USA
www.beckerorthopedic.com | Send Inquiry | Phone: +1-(248)-588-7480, (800)-521-2192
FDA Registration: 1824252
Products: Lower Extremity Splints, Lumbosacral Braces, Cervico-Thoracic Braces, Orthoses Cervico-Thoracic Braces, Cervicothoracic Lumbar Orthosis, Orthoses, Lumbosacral Braces, ...
Becker Orthopedic provides orthotic components and central fabrication services. We specialize in rotational control lower extremity laminated orthoses. We deliver a complete lower limb, thermoplastic more...
www.beckerorthopedic.com | Send Inquiry | Phone: +1-(248)-588-7480, (800)-521-2192
FDA Registration: 1824252
Products: Lower Extremity Splints, Lumbosacral Braces, Cervico-Thoracic Braces, Orthoses Cervico-Thoracic Braces, Cervicothoracic Lumbar Orthosis, Orthoses, Lumbosacral Braces, ...
Becker Orthopedic provides orthotic components and central fabrication services. We specialize in rotational control lower extremity laminated orthoses. We deliver a complete lower limb, thermoplastic more...
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FDA Code / Regulation: ITW / 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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