Abdominal Orthosis Suppliers
Limit companies to: Worldwide USA
Patterson Medical Products, Inc. | Address: 1000 Remington Blvd., Suite 210, Bolingbrook, Illinois 60440-5117, USA 
www.sammonspreston.com | Send Inquiry | Phone: +001-(630)-378-6000
Year Established: 1977 Annual Revenues: USD 50-100 Million Employee Count: ~20
Products: Splints, Forceps (FDA Code: HTD), Scissors, Adhesive Surgical Paper, Exercise Boards, Casting Materials, ...
Sammons Preston manufactures forceps, exercise boards, orthopedics, pediatrics, sensory motor, goniometers and Knee/Ankle braces & supports. Our turtle therapy system is an economical package designed more...
www.sammonspreston.com | Send Inquiry | Phone: +001-(630)-378-6000
Year Established: 1977 Annual Revenues: USD 50-100 Million Employee Count: ~20
Products: Splints, Forceps (FDA Code: HTD), Scissors, Adhesive Surgical Paper, Exercise Boards, Casting Materials, ...
Sammons Preston manufactures forceps, exercise boards, orthopedics, pediatrics, sensory motor, goniometers and Knee/Ankle braces & supports. Our turtle therapy system is an economical package designed more...
Lohmann & Rauscher, Inc. | Address: 6001 SW Sixth Avenue, Suite 101, Topeka, Kansas 66615-1004, USA
www.-lrmed.-com | Send Inquiry | Phone: +1-(785)-862-1100
Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), ...
Lohmann & Rauscher, Inc. offers a large variety from classic medical products to modern therapy-adjusted systems and system solutions. We offer various products for wound care, dressing retention, sup more...
www.-lrmed.-com | Send Inquiry | Phone: +1-(785)-862-1100
Quality: ISO 9001:2000 and ISO 13485:2003 Certified
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), ...
Lohmann & Rauscher, Inc. offers a large variety from classic medical products to modern therapy-adjusted systems and system solutions. We offer various products for wound care, dressing retention, sup more...
Michigan Orthopedic Services, LLC | Address: 13450 Farmington Road, Livonia, Michigan 48150, USA
www.michortho.com | Send Inquiry | Phone: +1-(734)-513-8205
Products: Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), Corrective Shoe Orthosis (FDA Code: KNP), Limb Brace Orthosis (FDA Code: IQI), Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), ...
Michigan Orthopedic Services, LLC provides orthotic and prosthetic services. We offer upper & lower extremity orthosis, humeral & ulnar fracture braces, elbow braces, shoulder slings, knee immobilizer more...
www.michortho.com | Send Inquiry | Phone: +1-(734)-513-8205
Products: Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), Cervical Orthosis (FDA Code: IQK), Corrective Shoe Orthosis (FDA Code: KNP), Limb Brace Orthosis (FDA Code: IQI), Rigid Cervical-Thoracic Orthosis (FDA Code: IQF), ...
Michigan Orthopedic Services, LLC provides orthotic and prosthetic services. We offer upper & lower extremity orthosis, humeral & ulnar fracture braces, elbow braces, shoulder slings, knee immobilizer more...
Freeman | Address: 900 W. Chicago Road, Sturgis, Michigan 49091, USA
www.freemanmfg.com | Send Inquiry | Phone: +1-(269)-651-2371, 800-253-2091
FDA Registration: 1811757 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Adult Foot & Ankle Splints, Adult Hand & Wrist Splints, Ankle Braces & Supports, Back Supports, Ankle Foot Orthosis, Ankle Support, ...
Freeman is a manufacturer of orthopedic softgoods to the global healthcare community. Our products range in diversity from a full line of back support garments and spinal braces to home healthcare pro more...
www.freemanmfg.com | Send Inquiry | Phone: +1-(269)-651-2371, 800-253-2091
FDA Registration: 1811757 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Adult Foot & Ankle Splints, Adult Hand & Wrist Splints, Ankle Braces & Supports, Back Supports, Ankle Foot Orthosis, Ankle Support, ...
Freeman is a manufacturer of orthopedic softgoods to the global healthcare community. Our products range in diversity from a full line of back support garments and spinal braces to home healthcare pro more...
Accelerated Care Plus Corp. | Address: 4850 Joule Street, Bldg. A-1, Reno, Nevada 89502, USA
www.acplus.com | Send Inquiry | Phone: +1-(775)-685-4000, 800-350-1100
FDA Registration: 1911273
Products: Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Arm Sling with Foam Strap, Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), ...
Accelerated Care Plus Corp. is a provider of specialized rehabilitation programs for long-term care facility operators and rehabilitation service providers. Our programs provide proprietary, patented more...
www.acplus.com | Send Inquiry | Phone: +1-(775)-685-4000, 800-350-1100
FDA Registration: 1911273
Products: Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Arm Sling with Foam Strap, Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), ...
Accelerated Care Plus Corp. is a provider of specialized rehabilitation programs for long-term care facility operators and rehabilitation service providers. Our programs provide proprietary, patented more...
J. Knipper and Company, Inc. | Address: One Healthcare Way, Lakewood, New Jersey 08701, USA
www.knipper.com | Phone: +1-(732)-9057878
FDA Registration: 2246553
Products: Elastic Bandages (FDA Code: FQM), Healthcare Service, Information Systems, Condom, Contraceptive (FDA Code: HIS), Disposable Colostomy Appliance (FDA Code: EZS), Drug Wound Dressing (FDA Code: FRO), ...
J. Knipper and Company, Inc. provides healthcare marketing solutions. Our healthcare marketing solutions include direct-mail, fulfillment, sampling, database, and sales force management. more...
www.knipper.com | Phone: +1-(732)-9057878
FDA Registration: 2246553
Products: Elastic Bandages (FDA Code: FQM), Healthcare Service, Information Systems, Condom, Contraceptive (FDA Code: HIS), Disposable Colostomy Appliance (FDA Code: EZS), Drug Wound Dressing (FDA Code: FRO), ...
J. Knipper and Company, Inc. provides healthcare marketing solutions. Our healthcare marketing solutions include direct-mail, fulfillment, sampling, database, and sales force management. more...
ConvaTec Inc. | Address: 100 Headquarters Park Drive, Skillman, New Jersey 08558, USA
www.convatec.com | Send Inquiry | Phone: +1-(800)-422-8811
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Antibiotics, Antibiotics & Antifungal, Antibiotics & Antimicrobials, Antidiabetics, Antifungals & Antiseborrheics, Antihypertensives, ...
ConvaTec Inc. offers products and product-related services for ostomy care, skin care & advanced wound care. Our Versiva® is a premium foam composite dressing that synergistically combines foam wi more...
www.convatec.com | Send Inquiry | Phone: +1-(800)-422-8811
Annual Revenues: < USD 1 Million Employee Count: ~400 Quality: CE Certified
Products: Antibiotics, Antibiotics & Antifungal, Antibiotics & Antimicrobials, Antidiabetics, Antifungals & Antiseborrheics, Antihypertensives, ...
ConvaTec Inc. offers products and product-related services for ostomy care, skin care & advanced wound care. Our Versiva® is a premium foam composite dressing that synergistically combines foam wi more...
PS Products, LLC | Address: 329 Bradford Lane, Lansdale, Pennsylvania 19446, USA
Phone: +1-(215)-661-9595
Products: Abdominal Orthosis (FDA Code: KTD), ...
PS Products, LLC specializes in manufacturing abdominal orthosis. more...
Phone: +1-(215)-661-9595
Products: Abdominal Orthosis (FDA Code: KTD), ...
PS Products, LLC specializes in manufacturing abdominal orthosis. more...
Texas Orthopaedic Products & Services, L.L.C. | Address: 805 Riding Club Road, P.O. BOX 190, Rowlett, Texas 75087-2193, USA
topsproducts.com | Phone: +1-(972)-772-8776, 888-373-4009
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Adhesive Elastic Bandage Tape, Abdominal Binders (FDA Code: FSD), Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), Ankle Stabilizer, ...
Texas Orthopaedic Products & Services, L.L.C. designs and manufactures an extensive line of orthopedic soft goods, braces, immobilizers, sports injury products, and related items that stabilize,and tr more...
topsproducts.com | Phone: +1-(972)-772-8776, 888-373-4009
Annual Revenues: < USD 1 Million Employee Count: ~10
Products: Adhesive Elastic Bandage Tape, Abdominal Binders (FDA Code: FSD), Arm Sling Strap Pads, Arm Sling Immobilizer, Abdominal Orthosis (FDA Code: KTD), Ankle Stabilizer, ...
Texas Orthopaedic Products & Services, L.L.C. designs and manufactures an extensive line of orthopedic soft goods, braces, immobilizers, sports injury products, and related items that stabilize,and tr more...
Advanced Orthotic Designs, Inc. | Address: 105 South State Street, No. 602, Orem, Utah 84058, USA
www.advancedorthoticdesigns.com | Send Inquiry | Phone: +1-(866)-4885650
FDA Registration: 3005844515
Products: Clamps, Abdominal Supports, Compression Instrument (FDA Code: HWN), Abdominal Orthosis (FDA Code: KTD), Lumbosacral Orthosis (FDA Code: IPY), Durable Orthosis, ...
Advanced Orthotic Designs, Inc. is engaged in the production of orthopedic and neurological spine products for medical professionals and patients. Our LaceIT™ X640 LSO & frame is designed with r more...
www.advancedorthoticdesigns.com | Send Inquiry | Phone: +1-(866)-4885650
FDA Registration: 3005844515
Products: Clamps, Abdominal Supports, Compression Instrument (FDA Code: HWN), Abdominal Orthosis (FDA Code: KTD), Lumbosacral Orthosis (FDA Code: IPY), Durable Orthosis, ...
Advanced Orthotic Designs, Inc. is engaged in the production of orthopedic and neurological spine products for medical professionals and patients. Our LaceIT™ X640 LSO & frame is designed with r more...
SPIO Inc. | Address: 26216 SE 108th Avenue, Kent, Washington 98030, USA
www.spioworks.com | Send Inquiry | Phone: +1-(253)-893-0390, 877-997-7746
FDA Registration: 3005979000
Products: Cervicothoracic Lumbar Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Abdominal Orthosis (FDA Code: KTD), Limb Brace Orthosis (FDA Code: IQI), Limb & Truncal Orthosis (FDA Code: MRI), ...
SPIO Inc. specializes in offering Stabilizing Pressure Input Orthosis (SPIO™) systems. Our SPIO™ systems assist patients with stability and proprioceptive deficits. They offer different pr more...
www.spioworks.com | Send Inquiry | Phone: +1-(253)-893-0390, 877-997-7746
FDA Registration: 3005979000
Products: Cervicothoracic Lumbar Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Abdominal Orthosis (FDA Code: KTD), Limb Brace Orthosis (FDA Code: IQI), Limb & Truncal Orthosis (FDA Code: MRI), ...
SPIO Inc. specializes in offering Stabilizing Pressure Input Orthosis (SPIO™) systems. Our SPIO™ systems assist patients with stability and proprioceptive deficits. They offer different pr more...
Thuasne North America | Address: 9415 Coppertop Loop, Suite D, Seattle, Washington 98110, USA
www.thuasnena.com | Send Inquiry | Phone: +1-(206)-8429177
Products: Elbow & Shoulder Orthoses, Back Orthoses, Ankle Foot Orthosis, Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), ...
Thuasne North America deals with healthcare and medical solutions. Our range of solutions will meet needs of a broad audience depending on their condition, morphology or activity. Some of our products more...
www.thuasnena.com | Send Inquiry | Phone: +1-(206)-8429177
Products: Elbow & Shoulder Orthoses, Back Orthoses, Ankle Foot Orthosis, Abdominal Orthosis (FDA Code: KTD), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), ...
Thuasne North America deals with healthcare and medical solutions. Our range of solutions will meet needs of a broad audience depending on their condition, morphology or activity. Some of our products more...
Homecraft Rolyan | Address: Nunn Brook Road, Huthwaite, Sutton in Ashfield, Nottinghamshire NG17 2HU, United Kingdom 
www.homecraft-rolyan.com | Phone: +44-(1623)-448706
FDA Registration: 9681624
Products: Non AC-Powered Patient Lift (FDA Code: FSA), Crutch (FDA Code: IPR), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Walker (FDA Code: ITJ), Non-Measuring Exerciser (FDA Code: ION), Chair with Casters (FDA Code: INM), ...
Homecraft Rolyan is a supplier of physical therapy products and equipment solutions to improve the independence & quality of life for disabled people of all ages, the elderly, & anyone who requires as more...
www.homecraft-rolyan.com | Phone: +44-(1623)-448706
FDA Registration: 9681624
Products: Non AC-Powered Patient Lift (FDA Code: FSA), Crutch (FDA Code: IPR), Mechanical Adjustable Chair (FDA Code: INN), Mechanical Walker (FDA Code: ITJ), Non-Measuring Exerciser (FDA Code: ION), Chair with Casters (FDA Code: INM), ...
Homecraft Rolyan is a supplier of physical therapy products and equipment solutions to improve the independence & quality of life for disabled people of all ages, the elderly, & anyone who requires as more...
Yasco Enterprise Corp. | Address: No. 211, Te Hsin Le, Pu Tzu City, Chia Yi Hsien 61359, Taiwan 
www.yasco.com.tw | Send Inquiry | Phone: +886-(5)-379-5155
FDA Registration: 3003902312
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Medical Support Stocking (FDA Code: FQL), Clavicle Splint (FDA Code: IQJ), External Brace Knee Joint (FDA Code: ITQ), ...
Yasco Enterprise Corp manufactures medical products, health care products and sports protections. Our products include medical products and health care products. Our medical products include bandages more...
www.yasco.com.tw | Send Inquiry | Phone: +886-(5)-379-5155
FDA Registration: 3003902312
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Medical Support Stocking (FDA Code: FQL), Clavicle Splint (FDA Code: IQJ), External Brace Knee Joint (FDA Code: ITQ), ...
Yasco Enterprise Corp manufactures medical products, health care products and sports protections. Our products include medical products and health care products. Our medical products include bandages 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), 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...
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), 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), Powered External Limb Component, Wrist Joint (FDA Code: KGH), ...
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), 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), Powered External Limb Component, Wrist Joint (FDA Code: KGH), ...
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...
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...
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...
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...
Osim Intl. (s) Pte Ltd. | Address: 65 Ubi Avenue 1, Singapore 408939, Singapore
www.OSIM.com | Phone: +65-(67)-476866
FDA Registration: 9612061
Products: Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Continuous Electronic Thermometer (FDA Code: FLL), Medical Insoles (FDA Code: KYS), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), Abdominal Orthosis (FDA Code: KTD), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Osim Intl. (s) Pte Ltd. provides healthy lifestyle products. Our products include blood pressure devices, magnetic slim belt, digital thermometer, air walkers, and pulse massagers. more...
www.OSIM.com | Phone: +65-(67)-476866
FDA Registration: 9612061
Products: Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), Continuous Electronic Thermometer (FDA Code: FLL), Medical Insoles (FDA Code: KYS), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), Abdominal Orthosis (FDA Code: KTD), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Osim Intl. (s) Pte Ltd. provides healthy lifestyle products. Our products include blood pressure devices, magnetic slim belt, digital thermometer, air walkers, and pulse massagers. more...
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FDA Code / Regulation: KTD / 890.3490
A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
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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