Lumbar Orthosis, Brace Suppliers
Limit companies to: Worldwide USA
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: Cervicothoracic Lumbar Orthosis, Arm Slings (FDA Code: ILI), Hand & Wrist Orthotic Kits, Foot Orthotic Kits, Disposable Arm Slings, Envelope Arm Sling, ...
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: Cervicothoracic Lumbar Orthosis, Arm Slings (FDA Code: ILI), Hand & Wrist Orthotic Kits, Foot Orthotic Kits, Disposable Arm Slings, Envelope Arm Sling, ...
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...
Slendertone Distribution Inc. | Address: 50 Harrison St., Suite 114, Hoboken, New Jersey 07030, USA
www.slendertoneusa.com | Send Inquiry | Phone: +1-(201)-800-551-2443
FDA Registration: 3006097619
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Cutaneous Electrode (FDA Code: GXY), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), Electrical-Powered Muscle Stimulator (FDA Code: IPF), External Brace Knee Joint (FDA Code: ITQ), Powered Muscle Stimulator For Muscle Conditioning (FDA Code: NGX), ...
Slendertone offers multiple products which helps in fitness and toning goals. We offer clinically demonstrated, medical grade solution to get firm, sexy abs, reduce the wiggle in triceps, or firm and more...
www.slendertoneusa.com | Send Inquiry | Phone: +1-(201)-800-551-2443
FDA Registration: 3006097619
Products: Lumbar Orthosis, Brace (FDA Code: IQE), Cutaneous Electrode (FDA Code: GXY), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), Electrical-Powered Muscle Stimulator (FDA Code: IPF), External Brace Knee Joint (FDA Code: ITQ), Powered Muscle Stimulator For Muscle Conditioning (FDA Code: NGX), ...
Slendertone offers multiple products which helps in fitness and toning goals. We offer clinically demonstrated, medical grade solution to get firm, sexy abs, reduce the wiggle in triceps, or firm and more...
Posture Dynamics, Inc. | Address: 415 Jarob Court, Point Pleasant, New Jersey 08742, USA
Send Inquiry | Phone: +1-(732)-278-2081
Products: Cervicothoracic Lumbar Orthosis, Lumbar Orthosis, Brace (FDA Code: IQE), Electric Position Chair (FDA Code: INO), ...
Posture Dynamics, Inc. we provides of biophysiometer is a computer aided positioning chair, which helps to balance the patient's spine by using the pelvis as a fulcrum. more...
Send Inquiry | Phone: +1-(732)-278-2081
Products: Cervicothoracic Lumbar Orthosis, Lumbar Orthosis, Brace (FDA Code: IQE), Electric Position Chair (FDA Code: INO), ...
Posture Dynamics, Inc. we provides of biophysiometer is a computer aided positioning chair, which helps to balance the patient's spine by using the pelvis as a fulcrum. more...
Accu-Med Technologies, Inc. | Address: 160 Bud-mil Dr., Buffalo, New York 14206, USA
www.accumedtech.com | Phone: +1-(716)-853-1800
Products: Wheelchair Accessories (FDA Code: KNO), Foley Catheter Holders (FDA Code: EYJ), Arm Slings (FDA Code: ILI), Ureteral Catheter Holder (FDA Code: EYJ), Lumbar Orthosis, Brace (FDA Code: IQE), Gas Mask Head Strap (FDA Code: BTK), ...
Accu-Med Technologies, Inc. offers a wide range of custom fabric development, manufacturing capabilities and associated services. We also provide design assistance, prototype development, testing and more...
www.accumedtech.com | Phone: +1-(716)-853-1800
Products: Wheelchair Accessories (FDA Code: KNO), Foley Catheter Holders (FDA Code: EYJ), Arm Slings (FDA Code: ILI), Ureteral Catheter Holder (FDA Code: EYJ), Lumbar Orthosis, Brace (FDA Code: IQE), Gas Mask Head Strap (FDA Code: BTK), ...
Accu-Med Technologies, Inc. offers a wide range of custom fabric development, manufacturing capabilities and associated services. We also provide design assistance, prototype development, testing and more...
Everson Chb Inc. | Address: 104 So Central Ave, 20, N Valley Stream, New York 11580, USA
Phone: +1-(718)-244-5330
FDA Registration: 3007309299
Products: Wheelchair Accessories (FDA Code: KNO), Foley Catheter Holders (FDA Code: EYJ), Ureteral Catheter Holder (FDA Code: EYJ), Lumbar Orthosis, Brace (FDA Code: IQE), Gas Mask Head Strap (FDA Code: BTK), Tracheal Tube Fixation Device (FDA Code: CBH), ...
Everson Chb Inc. is a provider of limb brace orthosis, colostomy pouch, and wheelchair accessories. more...
Phone: +1-(718)-244-5330
FDA Registration: 3007309299
Products: Wheelchair Accessories (FDA Code: KNO), Foley Catheter Holders (FDA Code: EYJ), Ureteral Catheter Holder (FDA Code: EYJ), Lumbar Orthosis, Brace (FDA Code: IQE), Gas Mask Head Strap (FDA Code: BTK), Tracheal Tube Fixation Device (FDA Code: CBH), ...
Everson Chb Inc. is a provider of limb brace orthosis, colostomy pouch, and wheelchair accessories. more...
Orfit Industries America | Address: 626 Reckson Plaza, Uniondale, New York 11556, USA
www.orfit.com | Send Inquiry | Phone: +1-(516)-522-2662
FDA Registration: 3005518451 Employee Count: ~30 Quality: ISO 9001, ISO 9002, CE Certified
Products: Contract Manufacturers, Hip Orthoses, Computed Tomography, Casting Materials and Equipment, Casting Stands, Post-Operative Hip Orthoses, Pediatric Hip Orthoses, ...
Orfit Industries America develops and produces thermoplastic materials for immobilization & fixation purposes in medical applications. We are accredited with ISO 9001:2000 certification. more...
www.orfit.com | Send Inquiry | Phone: +1-(516)-522-2662
FDA Registration: 3005518451 Employee Count: ~30 Quality: ISO 9001, ISO 9002, CE Certified
Products: Contract Manufacturers, Hip Orthoses, Computed Tomography, Casting Materials and Equipment, Casting Stands, Post-Operative Hip Orthoses, Pediatric Hip Orthoses, ...
Orfit Industries America develops and produces thermoplastic materials for immobilization & fixation purposes in medical applications. We are accredited with ISO 9001:2000 certification. more...
Ventlab Corporation | Address: 155 Boyce Drive, Mocksville, North Carolina 27028, USA
www.ventlab.com | Send Inquiry | Phone: +1-(336)-753-5000
FDA Registration: 2246980 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~90 Quality: ISO 9001 Certified
Products: Oxygen Masks (FDA Code: BYG), Face Masks, Face Mask Removers, Full Face Masks, Resuscitators Disposable, Disposable Manual Resuscitation Bags, Resuscitators Reusable, Reusable Manual Resuscitation Bags, ...
Ventlab Corporation designs and manufactures medical devices used in anesthesia, respiratory care, critical care & emergency medical services. Our airflow resuscitation bag is used to increase the pro more...
www.ventlab.com | Send Inquiry | Phone: +1-(336)-753-5000
FDA Registration: 2246980 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~90 Quality: ISO 9001 Certified
Products: Oxygen Masks (FDA Code: BYG), Face Masks, Face Mask Removers, Full Face Masks, Resuscitators Disposable, Disposable Manual Resuscitation Bags, Resuscitators Reusable, Reusable Manual Resuscitation Bags, ...
Ventlab Corporation designs and manufactures medical devices used in anesthesia, respiratory care, critical care & emergency medical services. Our airflow resuscitation bag is used to increase the pro 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, Knee Braces, Elastic Bandages (FDA Code: FQM), Lumbar Sacral Support, Arm Support Extender:, Toilet Aids, Toilet Safety Arm Support, ...
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, Knee Braces, Elastic Bandages (FDA Code: FQM), Lumbar Sacral Support, Arm Support Extender:, Toilet Aids, Toilet Safety Arm Support, ...
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...
Fillauer Companies, Inc. | Address: 2710 Amnicola Hwy., Chattanooga, Tennessee 37406-0189, USA
www.fillauer.com | Send Inquiry | Phone: +1-(423)-624-0946, 800-251-6398
FDA Registration: 1022826 Year Established: 1914 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Cervicothoracic Lumbar Orthosis, Leg Prosthesis, Arm Prosthesis, Hip Abduction Orthosis, Knee Rehab Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), ...
Fillauer Companies, Inc. is a manufacturer of orthotic and prosthetic products. Our swing phase lock is mounted on the lateral side. In this, the control joint uses friction to regulate knee flexion w more...
www.fillauer.com | Send Inquiry | Phone: +1-(423)-624-0946, 800-251-6398
FDA Registration: 1022826 Year Established: 1914 Annual Revenues: USD 10-25 Million Employee Count: ~110 Quality: ISO 9001, CE Certified
Products: Cervicothoracic Lumbar Orthosis, Leg Prosthesis, Arm Prosthesis, Hip Abduction Orthosis, Knee Rehab Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), ...
Fillauer Companies, Inc. is a manufacturer of orthotic and prosthetic products. Our swing phase lock is mounted on the lateral side. In this, the control joint uses friction to regulate knee flexion w 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: Biofeedback & Electrotherapy, Heat or Cold Packs, Orthopedic Cushions, Patient Lifters (FDA Code: FNG), Ultrasounds, Hand 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: Biofeedback & Electrotherapy, Heat or Cold Packs, Orthopedic Cushions, Patient Lifters (FDA Code: FNG), Ultrasounds, Hand 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...
Boston Brace International, Inc. | Address: 1600 Century Center Pkwy. Suite 110, Memphis, Tennessee 38134, USA
Phone: +1-(508)-588-6060
Products: Cervicothoracic Lumbar Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), Lumbosacral Orthosis (FDA Code: IPY), Limb & Truncal Orthosis (FDA Code: MRI), ...
Boston Brace International inc. we also offers lumbar-sacral orthoses, thoracic-lumbar-sacral orthosis, truncal orthoses. more...
Phone: +1-(508)-588-6060
Products: Cervicothoracic Lumbar Orthosis, Cervical Thoracic Orthosis (FDA Code: IPT), Lumbar Orthosis, Brace (FDA Code: IQE), Thoracic Orthosis, Brace (FDA Code: IPT), Lumbosacral Orthosis (FDA Code: IPY), Limb & Truncal Orthosis (FDA Code: MRI), ...
Boston Brace International inc. we also offers lumbar-sacral orthoses, thoracic-lumbar-sacral orthosis, truncal orthoses. more...
Alex Orthopedic, Inc. | Address: PO Box 201442, Arlington, Texas 76006-1442, USA
www.alexorthopedic.com | Send Inquiry | Phone: +1-(972)-641-9680, 800-544-2539
FDA Registration: 1641302 Year Established: 1986 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Orthopedic Cervical Collars, Cervical Collars, Hand and Thumb Splints, Elbow Braces & Supports, Tennis Elbow Brace, Splints, Frog, ...
Alex Orthopedic, Inc. provides canes and walking sticks. Our immobilizer support features complete circumferential support, lateral as well as anterior/posterior. It has a two-piece design with front more...
www.alexorthopedic.com | Send Inquiry | Phone: +1-(972)-641-9680, 800-544-2539
FDA Registration: 1641302 Year Established: 1986 Annual Revenues: USD 1-5 Million Employee Count: ~20
Products: Orthopedic Cervical Collars, Cervical Collars, Hand and Thumb Splints, Elbow Braces & Supports, Tennis Elbow Brace, Splints, Frog, ...
Alex Orthopedic, Inc. provides canes and walking sticks. Our immobilizer support features complete circumferential support, lateral as well as anterior/posterior. It has a two-piece design with front 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: Tubular Elastic Bandages & Nets, Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Self Adhesive Elastic Bandage, Cervicothoracic Lumbar Orthosis, Cohesive Elastic Bandage, ...
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: Tubular Elastic Bandages & Nets, Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Self Adhesive Elastic Bandage, Cervicothoracic Lumbar Orthosis, Cohesive Elastic Bandage, ...
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...
Premier Medical Equipment Inc | Address: 453 Bertrand Dr., Lafayette, Vermont 70506, USA
www.premier-medical.com | Phone: +1-(337)-237-1130
Products: Manual Wheelchairs, Wheelchair Cushions, Oxygen Concentrators, Power Wheelchairs, Oxygen Therapy, Concentrators, Electric Hospital Bed, ...
Premier Medical Equipment Inc specializes in providing madical supplies. Our products include respiratory products, hospital beds, bath safety aids, diabetic supplies and mobility solutions & rehab eq more...
www.premier-medical.com | Phone: +1-(337)-237-1130
Products: Manual Wheelchairs, Wheelchair Cushions, Oxygen Concentrators, Power Wheelchairs, Oxygen Therapy, Concentrators, Electric Hospital Bed, ...
Premier Medical Equipment Inc specializes in providing madical supplies. Our products include respiratory products, hospital beds, bath safety aids, diabetic supplies and mobility solutions & rehab eq 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), Thoracic Orthosis, Brace (FDA Code: IPT), Abdominal Orthosis (FDA Code: KTD), Limb Brace Orthosis (FDA Code: IQI), ...
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), Thoracic Orthosis, Brace (FDA Code: IPT), Abdominal Orthosis (FDA Code: KTD), Limb Brace Orthosis (FDA Code: IQI), ...
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...
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), Lumbar Orthosis, Brace (FDA Code: IQE), Adhesive Tape Solvent (FDA Code: KOX), Medical Insoles (FDA Code: KYS), ...
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), Lumbar Orthosis, Brace (FDA Code: IQE), Adhesive Tape Solvent (FDA Code: KOX), Medical Insoles (FDA Code: KYS), ...
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: Ankle Braces, Elbow Braces, Foot Braces, Knee Braces, Hand and Wrist Braces, Walkers, ...
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: Ankle Braces, Elbow Braces, Foot Braces, Knee Braces, Hand and Wrist Braces, Walkers, ...
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...
Promedics Ltd. | Address: Moorgate Street, Blackburn BB2 4PB, United Kingdom 
www.promedics.co.uk | Send Inquiry | Phone: +44-(1475)-746400
Products: Cervicothoracic Lumbar Orthosis, 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), ...
Promedics Ltd. offers lumbar support and elastic wrist brace. We also provide cervical collar and Genurange universal elastic ankle wrap. more...
www.promedics.co.uk | Send Inquiry | Phone: +44-(1475)-746400
Products: Cervicothoracic Lumbar Orthosis, 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), ...
Promedics Ltd. offers lumbar support and elastic wrist brace. We also provide cervical collar and Genurange universal elastic ankle wrap. more...
I-Ming Sanitary Materials Co.,Ltd. | Address: 101-10 Du Tu Lane., Er Hsi Rd, Peishih Li Hsihu, Chang Hua 514, Taiwan 
www.supports.com.tw | Send Inquiry | Phone: +886-(4)-8819638
FDA Registration: 9616933 Quality: ISO9001, ISO13488 Certified
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Lumbar Orthosis, Brace (FDA Code: IQE), Compressible Limb Sleeve (FDA Code: JOW), ...
I-Ming Sanitary Materials Co.,Ltd. specializes in designing and manufacturing orthopedics, rehabilitation, health care and sporting supports. Our product range includes health back supports, abdominal more...
www.supports.com.tw | Send Inquiry | Phone: +886-(4)-8819638
FDA Registration: 9616933 Quality: ISO9001, ISO13488 Certified
Products: Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Abdominal Binders (FDA Code: FSD), Lumbar Orthosis, Brace (FDA Code: IQE), Compressible Limb Sleeve (FDA Code: JOW), ...
I-Ming Sanitary Materials Co.,Ltd. specializes in designing and manufacturing orthopedics, rehabilitation, health care and sporting supports. Our product range includes health back supports, abdominal more...
Orthoplus International Corporation Limited | Address: 7f-1, No.39, Shaw Nien Street, Hsinchu 300, Taiwan
Phone: +886-(3)-5281210
FDA Registration: 3006617872
Products: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), Non-Powered Traction Apparatus (FDA Code: HST), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), ...
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: Arm Slings (FDA Code: ILI), Arm Supports (FDA Code: IOY), Lumbar Orthosis, Brace (FDA Code: IQE), Non-Powered Traction Apparatus (FDA Code: HST), Hand Splint and Component (FDA Code: ILH), External Ankle Brace (FDA Code: ITW), ...
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...
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FDA Code / Regulation: IQE / 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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