Lumbosacral Orthosis Suppliers
Limit companies to: Worldwide USA
Judah Manufacturing Corporation | Address: 13657 Jupiter Road, #100, Dallas, Texas 65238, USA 
www.judahmanufacturing.com | Send Inquiry | Phone: +1-(214)-340-6200, 800-618-9792
FDA Registration: 1651179 Year Established: 1997 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Adhesive Elastic Bandage Tape, Cervical Collars, Adjustable Knee Brace, Cervical Neck Collar, Cartilage Knee Sleeves, Ankle Stirrups, ...
Judah Manufacturing Corporation specializes in offering various medical equipment. Our products include stimulators, conductive garments, electrodes/leads, nutritional supplements, pillows, exercise e more...
www.judahmanufacturing.com | Send Inquiry | Phone: +1-(214)-340-6200, 800-618-9792
FDA Registration: 1651179 Year Established: 1997 Annual Revenues: < USD 1 Million Employee Count: ~20
Products: Adhesive Elastic Bandage Tape, Cervical Collars, Adjustable Knee Brace, Cervical Neck Collar, Cartilage Knee Sleeves, Ankle Stirrups, ...
Judah Manufacturing Corporation specializes in offering various medical equipment. Our products include stimulators, conductive garments, electrodes/leads, nutritional supplements, pillows, exercise e 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...
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...
Three-D Orthopedic, Div. Deroyal Industries, Inc. | Address: 101 Rose Hill Industrial Park, Rose Hill, Virginia 24281, USA
Phone: +1-(865)-938-7828
Products: Adhesive Elastic Bandage Tape, Cast Covers (FDA Code: KIA), Arm Slings (FDA Code: ILI), Arm Sling with Foam Strap, Arm Sling Strap Pads, Arm Sling Immobilizer, ...
Three-D Orthopedic, Div. Deroyal Industries, Inc. is a provider of various ankle supports and braces. Our product line include knee immobilizers, pelvic traction, elbow supports, protective restraints more...
Phone: +1-(865)-938-7828
Products: Adhesive Elastic Bandage Tape, Cast Covers (FDA Code: KIA), Arm Slings (FDA Code: ILI), Arm Sling with Foam Strap, Arm Sling Strap Pads, Arm Sling Immobilizer, ...
Three-D Orthopedic, Div. Deroyal Industries, Inc. is a provider of various ankle supports and braces. Our product line include knee immobilizers, pelvic traction, elbow supports, protective restraints 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...
Myotronics-Normed Inc | Address: 5870 S 194th Street Kent, Tukwila, Washington 98032-2125, USA
www.noromed.com | Phone: +1-(206)-243-4214
FDA Registration: 3013226 Year Established: 1974 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Adhesive Strips & Patches, Skin Closure Adhesive Strips (FDA Code: FPX), Self Adhesive Strips (FDA Code: FPX), Electromyography Device, Microfoam Adhesive Strip, Emergency First Aid Kit (FDA Code: LRR), ...
Myotronics-Normed Inc specializes in designing and manufacturing surface electromyography dynamic range of motion and muscle testing devices. We focus on evaluation & rehabilitation applications in ph more...
www.noromed.com | Phone: +1-(206)-243-4214
FDA Registration: 3013226 Year Established: 1974 Annual Revenues: USD 1-5 Million Employee Count: ~50
Products: Adhesive Strips & Patches, Skin Closure Adhesive Strips (FDA Code: FPX), Self Adhesive Strips (FDA Code: FPX), Electromyography Device, Microfoam Adhesive Strip, Emergency First Aid Kit (FDA Code: LRR), ...
Myotronics-Normed Inc specializes in designing and manufacturing surface electromyography dynamic range of motion and muscle testing devices. We focus on evaluation & rehabilitation applications in ph more...
La Pointique International Ltd. | Address: 1030 Industry Dr., No. 32-C, Tukwila, Washington 98188, USA
www.lp-support.com | Send Inquiry | Phone: +1-(206)-5758843
FDA Registration: 3023471
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Cast Bandage (FDA Code: ITG), Cervical Orthosis (FDA Code: IQK), Clavicle Splint (FDA Code: IQJ), ...
La Pointique International Ltd. develops products for body parts protection and sports protection. Our products include coolprene®, nanometer and Maxwrap®. Our coolprene® is based on theor more...
www.lp-support.com | Send Inquiry | Phone: +1-(206)-5758843
FDA Registration: 3023471
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Cast Bandage (FDA Code: ITG), Cervical Orthosis (FDA Code: IQK), Clavicle Splint (FDA Code: IQJ), ...
La Pointique International Ltd. develops products for body parts protection and sports protection. Our products include coolprene®, nanometer and Maxwrap®. Our coolprene® is based on theor more...
Darco International, Inc. | Address: 810 Memorial Blvd., Huntington, West Virginia 25701, USA
www.darcointernational.com | Send Inquiry | Phone: +1-(304)-522-4883
FDA Registration: 3006026111 Year Established: 1985 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Crutches, Canes, Walkers, Insoles & Footwear, Knee/Ankle Braces & Supports, General Medical Supplies, General Orthopedic Supplies, Shoes & Boots, ...
Darco International Inc manufactures orthopedic soft goods in the medical/surgical industry. The all purpose boot can be used as a post operative shoe and a cast boot. The closed toe protection allows more...
www.darcointernational.com | Send Inquiry | Phone: +1-(304)-522-4883
FDA Registration: 3006026111 Year Established: 1985 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: Crutches, Canes, Walkers, Insoles & Footwear, Knee/Ankle Braces & Supports, General Medical Supplies, General Orthopedic Supplies, Shoes & Boots, ...
Darco International Inc manufactures orthopedic soft goods in the medical/surgical industry. The all purpose boot can be used as a post operative shoe and a cast boot. The closed toe protection allows more...
Mueller Sports Medicine, Inc. | Address: One Quench Drive, Prairie du Sac, Wisconsin 53578, USA
www.muellersportsmed.com | Send Inquiry | Phone: +1-(608)-643-8530
FDA Registration: 2110420 Year Established: 1961 Annual Revenues: USD 50-100 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Scissors, Adhesive Elastic, Adhesive Strips & Patches, Analgesics, Anesthetics, Athletic Cloth, ...
Mueller Sports Medicine, Inc. manufactures products for athletes worldwide. Our product line includes analgesics, cold & hot therapy, exercise & fitness, foot care, grip enhancers, mouth guards, sungl more...
www.muellersportsmed.com | Send Inquiry | Phone: +1-(608)-643-8530
FDA Registration: 2110420 Year Established: 1961 Annual Revenues: USD 50-100 Million Employee Count: ~120 Quality: ISO, CE Certified
Products: Scissors, Adhesive Elastic, Adhesive Strips & Patches, Analgesics, Anesthetics, Athletic Cloth, ...
Mueller Sports Medicine, Inc. manufactures products for athletes worldwide. Our product line includes analgesics, cold & hot therapy, exercise & fitness, foot care, grip enhancers, mouth guards, sungl more...
The Spinecorporation Ltd. | Address: Millennium House, Peak Business Park, Foxwood Road, Chesterfield S41 9RF, United Kingdom 
www.spinecorporation.com | Send Inquiry | Phone: +44-(1246)-454682
FDA Registration: 3003988753
Products: Elastic Bandages (FDA Code: FQM), Medical Training Service, Educational Service, Limb Brace Orthosis (FDA Code: IQI), Lumbosacral Orthosis (FDA Code: IPY), Patient Data Transmission And Storage Software (FDA Code: NSX), ...
The Spinecorporation Ltd. is engaged in the production of corrective brace products. Our product line comprises of Spinecor brace, SpineCor assistant software and postural measure system. We supply Sp more...
www.spinecorporation.com | Send Inquiry | Phone: +44-(1246)-454682
FDA Registration: 3003988753
Products: Elastic Bandages (FDA Code: FQM), Medical Training Service, Educational Service, Limb Brace Orthosis (FDA Code: IQI), Lumbosacral Orthosis (FDA Code: IPY), Patient Data Transmission And Storage Software (FDA Code: NSX), ...
The Spinecorporation Ltd. is engaged in the production of corrective brace products. Our product line comprises of Spinecor brace, SpineCor assistant software and postural measure system. We supply Sp more...
Lifeforever Industrial Company | Address: No. 38, Lane 325, Ping-An Street, Changhua 500, Taiwan 
Phone: +886-(11)-47514357
Products: Elastic Bandages (FDA Code: FQM), Cast Shoe (FDA Code: IPG), Corrective Shoe Orthosis (FDA Code: KNP), Lumbosacral Orthosis (FDA Code: IPY), ...
Lifeforever Industrial Company focuses on cast shoes, corrective shoe orthosis, elastic bandages and lumbosacral orthosis. more...
Phone: +886-(11)-47514357
Products: Elastic Bandages (FDA Code: FQM), Cast Shoe (FDA Code: IPG), Corrective Shoe Orthosis (FDA Code: KNP), Lumbosacral Orthosis (FDA Code: IPY), ...
Lifeforever Industrial Company focuses on cast shoes, corrective shoe orthosis, elastic bandages and lumbosacral orthosis. more...
Samderson Life Medical Industries Corporation | Address: No. 27, Lane 743, Sec. 5, Zhongxiao East Road, Hsin Yi District, Taipei 110, Taiwan
www.samderson.com | Send Inquiry | Phone: +886-(2)-8785-3826
FDA Registration: 3007538819
Products: Cervical Collars, Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Cervical Thoracic Orthosis (FDA Code: IPT), Ankle Walker Braces, Cervical Orthosis (FDA Code: IQK), ...
Samderson Life Medical Industries Corporation manufactures medical supportive products. Our products include ankle supports & braces, arm slings or immobilizers, cervical collars, clavicle supports & more...
www.samderson.com | Send Inquiry | Phone: +886-(2)-8785-3826
FDA Registration: 3007538819
Products: Cervical Collars, Arm Slings (FDA Code: ILI), Abdominal Binders (FDA Code: FSD), Cervical Thoracic Orthosis (FDA Code: IPT), Ankle Walker Braces, Cervical Orthosis (FDA Code: IQK), ...
Samderson Life Medical Industries Corporation manufactures medical supportive products. Our products include ankle supports & braces, arm slings or immobilizers, cervical collars, clavicle supports & more...
Orthoplus International Corporation Limited | Address: 7f-1, No.39, Shaw Nien Street, Hsinchu 300, Taiwan
Phone: +886-(3)-5281210
FDA Registration: 3006617872
Products: Lumbar Orthosis, Brace (FDA Code: IQE), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Knee Cage (FDA Code: ITM), Limb & Truncal Orthosis (FDA Code: MRI), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
Orthoplus International Corporation Limited offers health-care products such as arm slings, clavicle splints, external ankle braces, limb brace orthosis, rigid cervical-thoracic orthosis, knee cages, more...
Phone: +886-(3)-5281210
FDA Registration: 3006617872
Products: Lumbar Orthosis, Brace (FDA Code: IQE), External Ankle Brace (FDA Code: ITW), External Brace Knee Joint (FDA Code: ITQ), Knee Cage (FDA Code: ITM), Limb & Truncal Orthosis (FDA Code: MRI), Truncal Orthosis For Dysmenorrhea (FDA Code: NJB), ...
Orthoplus International Corporation Limited offers health-care products such as arm slings, clavicle splints, external ankle braces, limb brace orthosis, rigid cervical-thoracic orthosis, knee cages, more...
Sound Medical Corp. | Address: 2nd Floor, 11 Tsu-Chiang, 1st Road, Nan-Tou 540, Taiwan
Phone: +886-(49)-225-4268
FDA Registration: 3004050637
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), External Limb Component, Ankle/Foot (FDA Code: ISH), External Limb Component Knee Joint (FDA Code: ISY), Limb Brace Orthosis (FDA Code: IQI), Mechanical External Limb Component Wrist Joint (FDA Code: ISZ), ...
Sound Medical Corp. offers arm supports, cast components, cervical orthosis, clavicle splints, external ankle braces and external brace knee joints. We supply external inflatable extremity splints, ex more...
Phone: +886-(49)-225-4268
FDA Registration: 3004050637
Products: Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), External Limb Component, Ankle/Foot (FDA Code: ISH), External Limb Component Knee Joint (FDA Code: ISY), Limb Brace Orthosis (FDA Code: IQI), Mechanical External Limb Component Wrist Joint (FDA Code: ISZ), ...
Sound Medical Corp. offers arm supports, cast components, cervical orthosis, clavicle splints, external ankle braces and external brace knee joints. We supply external inflatable extremity splints, ex more...
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: Lumbar Orthosis, Brace (FDA Code: IQE), 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), Limb Cover (FDA Code: IPM), ...
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: Lumbar Orthosis, Brace (FDA Code: IQE), 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), Limb Cover (FDA Code: IPM), ...
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), 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...
Link Treasure Limited Taiwan Branch | Address: No.22, Kuang-Fu Road, Chia-Tai Industrial, Tai Pao City, Chia Yi Hsien 61252, Taiwan
Phone: +886-(3)-5208829
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Powered Wheelchair (FDA Code: ITI), Disabled/Handicapped Motorized 3-Wheeled Vehicle (FDA Code: INI), ...
Link Treasure Limited Taiwan Branch offers AC-powered patient lifts, disabled and handicapped manual wheelchairs, disabled and handicapped motorized 3-wheeled vehicles & disabled and handicapped hygie more...
Phone: +886-(3)-5208829
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Powered Wheelchair (FDA Code: ITI), Disabled/Handicapped Motorized 3-Wheeled Vehicle (FDA Code: INI), ...
Link Treasure Limited Taiwan Branch offers AC-powered patient lifts, disabled and handicapped manual wheelchairs, disabled and handicapped motorized 3-wheeled vehicles & disabled and handicapped hygie more...
Tien Jiang Enterprise Co., Ltd. | Address: 3f.,No.20, Lane 619, Chung Hwa Rd.,Yung Kang City, Tainan Hsien 710, Taiwan
www.tienjiang.com.tw | Send Inquiry | Phone: +886-(6)-2313-002
FDA Registration: 3003849847
Products: Elastic Bandages (FDA Code: FQM), Elastic Athletic Supports, Elastic Support Hosiery, Arm Supports (FDA Code: IOY), External Ankle Brace (FDA Code: ITW), Knee Crutch Pads, ...
Tien Jiang Enterprise Co., Ltd. focuses on medical supports. Our products include protective wears, knee pads, neoprene cinches, elastic knitted supports, bandages and neoprene supports. We offer neop more...
www.tienjiang.com.tw | Send Inquiry | Phone: +886-(6)-2313-002
FDA Registration: 3003849847
Products: Elastic Bandages (FDA Code: FQM), Elastic Athletic Supports, Elastic Support Hosiery, Arm Supports (FDA Code: IOY), External Ankle Brace (FDA Code: ITW), Knee Crutch Pads, ...
Tien Jiang Enterprise Co., Ltd. focuses on medical supports. Our products include protective wears, knee pads, neoprene cinches, elastic knitted supports, bandages and neoprene supports. We offer neop more...
Masaki Trading Co., Ltd. | Address: 6th Floor, No. 554 Linsen North Rd., Taipei, Taiwan
Phone: +886-(757)-2240177
FDA Registration: 3008311900
Products: Medical Insoles (FDA Code: KYS), Microsurgical Ear Pick (FDA Code: JYT), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Lumbosacral Orthosis (FDA Code: IPY), Electric Therapeutic Massager (FDA Code: ISA), ...
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: Medical Insoles (FDA Code: KYS), Microsurgical Ear Pick (FDA Code: JYT), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), Lumbosacral Orthosis (FDA Code: IPY), Electric Therapeutic Massager (FDA Code: ISA), ...
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...
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FDA Code / Regulation: IPY / 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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