Non-Powered Traction Apparatus Suppliers
Limit companies to: Worldwide USA
Hayes Medical, Inc. | Address: 1115 Windfield Way, Ste. 100, El Dorado Hills, California 95762-9623, USA 
www.hayesmed.com | Send Inquiry | Phone: +1-(916)-355-7100
FDA Registration: 2952369 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Tibial Inserts, Patellar Implants, Hip Positioner Systems, Total Knee Systems, Compression Garments, Knee/Ankle Braces & Supports, ...
Hayes Medical, Inc. concentrates on the orthopaedic implant and instrument industry. Our Consensus® hip system offers the surgeon a variety of implant options, thus providing excellent performance more...
www.hayesmed.com | Send Inquiry | Phone: +1-(916)-355-7100
FDA Registration: 2952369 Year Established: 1992 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001, CE Certified
Products: Tibial Inserts, Patellar Implants, Hip Positioner Systems, Total Knee Systems, Compression Garments, Knee/Ankle Braces & Supports, ...
Hayes Medical, Inc. concentrates on the orthopaedic implant and instrument industry. Our Consensus® hip system offers the surgeon a variety of implant options, thus providing excellent performance more...
Depuy Orthopaedics, Inc. | Address: 4240 Holden Street, Emeryville, California 94608, USA
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Acetabular Liners, AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), AC-Powered Surgical Instrument Motor (FDA Code: GEY), 3 Part Metal-Plastic-Metal Articulation Wrist Prosthesis (FDA Code: JWJ), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Acetabular Mesh Hip Prosthesis (FDA Code: JDJ), ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
www.depuyorthopaedics.com | Send Inquiry | Phone: +1-(510)-597-4220
FDA Registration: 1818910 Year Established: 1895
Products: Acetabular Liners, AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX), AC-Powered Surgical Instrument Motor (FDA Code: GEY), 3 Part Metal-Plastic-Metal Articulation Wrist Prosthesis (FDA Code: JWJ), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Acetabular Mesh Hip Prosthesis (FDA Code: JDJ), ...
Depuy Orthopaedics, Inc. designs, manufactures and distributes orthopaedic devices & supplies including hip, knee, extremity, trauma, orthobiologics & operating room products. more...
The Back Bubble | Address: PO Box 1285, Solana Beach, California 92075, USA
backpainrelief.com | Send Inquiry | Phone: +001-(800)-457-7246
FDA Registration: 2031048
Products: Ergonomic Supplies, Back Bubble r, Non-Powered Traction Apparatus (FDA Code: HST), ...
The Back Bubble deals with pain relief products with significance to spine. We are FDA registered. Our Back Bubble® back pain relief product solves herniated disk problems, sciatica, and bulging d more...
backpainrelief.com | Send Inquiry | Phone: +001-(800)-457-7246
FDA Registration: 2031048
Products: Ergonomic Supplies, Back Bubble r, Non-Powered Traction Apparatus (FDA Code: HST), ...
The Back Bubble deals with pain relief products with significance to spine. We are FDA registered. Our Back Bubble® back pain relief product solves herniated disk problems, sciatica, and bulging d 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, General Medical Supplies, Surgical Tables, Arthroplasty Table, Imaging Stretcher, ...
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, General Medical Supplies, Surgical Tables, Arthroplasty Table, Imaging Stretcher, ...
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...
KLS Martin, L.P. | Address: 11239-1 St.Johns Industrial Parkway S, Jacksonville, Florida 32246-7652, USA
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate more...
www.klsmartinusa.com | Send Inquiry | Phone: +1-(904)-641-7746, 800-625-1557
FDA Registration: 1057946 Year Established: 1993 Annual Revenues: USD 10-25 Million Employee Count: ~100 Quality: ISO 9001 Certified
Products: Elevators, Instruments, Castroviejo Calipers, Neurological Instruments, Pituitary Scoops, Cervical Spine Retractor System, Hand Held Instruments, Periosteals Elevators, ...
KLS Martin, L.P. focuses on surgical fields. Our mario® instrument management software manages & controls sterile supplies according to economic, technical & process-oriented criteria. Our C-plate 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: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
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: Sinus Trochars and Cannulae, Surgical Navigation Interface/Display, Nerve Stimulators, Eyeshields, General Diagnostic Supplies, General Surgical Aids, ...
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...
Arthrex, Inc. | Address: 1370 Creekside Boulevard, Naples, Florida 34108-1945, USA
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo more...
www.arthrex.com | Phone: +1-(800)-933-7001
FDA Registration: 1220246
Products: Absorbable Suture Anchors, Absorbable Corkscrew Suture Anchor, Adhesive Bandage Strip, Absorbable Staple (FDA Code: MNU), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), ...
Arthrex provides quality products & educational services to meet the special needs of orthopaedic surgeons and their patients. We focus on creative product development and medical education. We develo more...
Vyaire Medical, Inc. | Address: 26125 North Riverwoods Blvd, Mettawa, Illinois 60045, USA
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l more...
www.vyaire.com | Send Inquiry | Phone: +1-(610)-862-0800
FDA Registration: 2050001 Year Established: 2001 Annual Revenues: USD 50-100 Million Employee Count: ~230 Quality: ISO 9001, CE Certified
Products: Speech & Testing Equipment, Impedance Testing Systems, Audiometers & Accessories, Evoked Response Testing Systems, Infant Screening & Testing Units, Otoacoustic Emission Test Equipment, ...
Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-l 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: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
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: Drills, Drills Accessories, High Speed Orthopedic Drills, Surgical Drills, Orbital Procedures, Bone Drills, Orthopedics, High Speed Drills System, ...
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...
DePuy Orthopaedics, Inc | Address: 700 Orthopaedic Drive, Warsaw, Indiana 46582, USA
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement more...
www.depuy.com | Send Inquiry | Phone: +1-(574)-267-8143, 800-473-3789
Year Established: 1895 Employee Count: ~600
Products: Bone Cement (FDA Code: LOD), Orthopedics, Compression Hip Screw, Free Lock Compression Hip Screws, FRS-Fusion and Reconstruction System, Acetabular Cup System, Mobile-Bearing Knee System, ...
DePuy, Inc., provides healthcare solutions in orthopaedics, spinal care, pain management, and central nervous system. Our orthopaedic devices and supplies include hip, knee, extremity, trauma, cement 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, Biofeedback Device (FDA Code: HCC), External Functional Neuromuscular Stimulator (FDA Code: GZI), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), ...
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, Biofeedback Device (FDA Code: HCC), External Functional Neuromuscular Stimulator (FDA Code: GZI), Transcutaneous Nerve Stimulator for Pain Relief (FDA Code: GZJ), ...
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...
Depuy Spine, Inc. | Address: 325 Paramount Drive, Raynham, Massachusetts 02767, USA
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
www.depuyacromed.com | Send Inquiry | Phone: +1-(508)-880-8100
FDA Registration: 1526439 Year Established: 1895
Products: Allografts, Anterior, Anterior Cruciate Ligament Surgical Reconstruction System, Anterior Cervical Plate, Anterior Lumbar Plate System, AC-Powered Surgical Instrument Motor (FDA Code: GEY), ...
Depuy Spine, Inc. designs, manufactures and sells orthopaedic devices & supplies. Our Devex™ System is indicated for use in the thoracolumbar spine to replace a diseased vertebral body resected more...
Bird & Cronin Inc. | Address: 1200 Trapp Road, Eagan, Minnesota 55121, USA
www.birdcronin.com | Send Inquiry | Phone: +1-(800)-328-1095
FDA Registration: 2182345
Products: Splints, Cast Boots, Ankle Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Bird and Cronin Inc. manufactures patient footwear, orthopedic soft goods and specialty patient care products. We offer products like cervical, upper extremities, lumbar/low back, lower extremities, c more...
www.birdcronin.com | Send Inquiry | Phone: +1-(800)-328-1095
FDA Registration: 2182345
Products: Splints, Cast Boots, Ankle Braces, Foot Braces, Shoulder Braces, Knee Braces, ...
Bird and Cronin Inc. manufactures patient footwear, orthopedic soft goods and specialty patient care products. We offer products like cervical, upper extremities, lumbar/low back, lower extremities, c more...
3M Medical Specialties | Address: 3M Center, St. Paul, Minnesota 55144-1000, USA
www.3m.com/us/healthcare/medicalspecialties | Send Inquiry | Phone: +1-(888)-364-3577
FDA Registration: 1717046
Products: Stethoscopes, Splints, Autoclaves, Thermometers, Sterilizing Aids, Adhesive Cloth, ...
3M Medical Specialties and OEM Products offers solutions, technologies and services for health care product development. We produce a wide range of medical tapes, diagnostic components and optical sup more...
www.3m.com/us/healthcare/medicalspecialties | Send Inquiry | Phone: +1-(888)-364-3577
FDA Registration: 1717046
Products: Stethoscopes, Splints, Autoclaves, Thermometers, Sterilizing Aids, Adhesive Cloth, ...
3M Medical Specialties and OEM Products offers solutions, technologies and services for health care product development. We produce a wide range of medical tapes, diagnostic components and optical sup more...
Corflex, Inc. | Address: 669 East Industrial Park Drive, Manchester, New Hampshire 03109, USA
www.corflex.com | Send Inquiry | Phone: +1-(603)-623.3344
FDA Registration: 1218997 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Foot Braces, Humeral Splints, Shoulder Braces, Knee Braces, ...
Corflex, Inc. manufactures & distributes orthopedic rehabilitation, sports medicine and orthotic products. We produce a broad range of over 250 products. We offer a comprehensive line of sports medici more...
www.corflex.com | Send Inquiry | Phone: +1-(603)-623.3344
FDA Registration: 1218997 Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: CE Certified
Products: Ankle Braces, Elbow Braces, Foot Braces, Humeral Splints, Shoulder Braces, Knee Braces, ...
Corflex, Inc. manufactures & distributes orthopedic rehabilitation, sports medicine and orthotic products. We produce a broad range of over 250 products. We offer a comprehensive line of sports medici more...
SAI Therapeutic Brands | Address: 3960 Rosslyn Drive, Cincinnati, Ohio 45209-1195, USA
surgicalappliance.com | Send Inquiry | Phone: +001-(800)-888-0458
Year Established: 1893 Annual Revenues: USD 25-50 Million Employee Count: ~350
Products: Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist Braces, Lumbosacral Braces, Skin Closures, Knee Braces, ...
SAI Therapeutic Brands deals with healthcare products. Our products are divided into four major brand categories such as Truform therapeutic compression hosiery, Truform OTC orthotics & prosthetics, A more...
surgicalappliance.com | Send Inquiry | Phone: +001-(800)-888-0458
Year Established: 1893 Annual Revenues: USD 25-50 Million Employee Count: ~350
Products: Ankle Braces, Elbow Braces, Knee Braces, Hand and Wrist Braces, Lumbosacral Braces, Skin Closures, Knee Braces, ...
SAI Therapeutic Brands deals with healthcare products. Our products are divided into four major brand categories such as Truform therapeutic compression hosiery, Truform OTC orthotics & prosthetics, A more...
Faretec, Inc. | Address: 1610 West Jackson St, Painesville, Ohio 44077, USA
www.faretec.com | Send Inquiry | Phone: +1-(440)-350-9510, 800-322-3273
FDA Registration: 1528440
Products: Splints, Finger Splints, Hand and Thumb Splints, Adult Foot & Ankle Splints, Expendable Bandages & Splints, Expendable Splints, ...
Faretec, Inc. deals with fracture and rehabilitation equipments. We have a wide range of splints. Our LifeBox50™ transport containers are designed to keep sensitive fluids at temperature for up more...
www.faretec.com | Send Inquiry | Phone: +1-(440)-350-9510, 800-322-3273
FDA Registration: 1528440
Products: Splints, Finger Splints, Hand and Thumb Splints, Adult Foot & Ankle Splints, Expendable Bandages & Splints, Expendable Splints, ...
Faretec, Inc. deals with fracture and rehabilitation equipments. We have a wide range of splints. Our LifeBox50™ transport containers are designed to keep sensitive fluids at temperature for up more...
Rapid Deployment Products | Address: 100 Steamwhistle Drive, Ivyland, Pennsylvania 18974, USA
www.prolitespineboards.com | Send Inquiry | Phone: +1-(215)-953-9190
Year Established: 1999 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: General EMT, Face Masks Padded, Anesthesia Face Masks, Bed Transfer Aids, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Rapid Deployment Products specializes in spinal immobilization equipment. Our product list comprises of back boards, multipurpose carriers, rescue pads, immobilizers, straps, yellow jacket splints and more...
www.prolitespineboards.com | Send Inquiry | Phone: +1-(215)-953-9190
Year Established: 1999 Annual Revenues: USD 1-5 Million Employee Count: ~20 Quality: CE Certified
Products: General EMT, Face Masks Padded, Anesthesia Face Masks, Bed Transfer Aids, Transfer Aid for Disabled/Handicapped (FDA Code: IKX), Transfer Aid (FDA Code: IKX), ...
Rapid Deployment Products specializes in spinal immobilization equipment. Our product list comprises of back boards, multipurpose carriers, rescue pads, immobilizers, straps, yellow jacket splints and more...
Wright Medical Technology, Inc. | Address: 5677 Airline Road, Arlington, Tennessee 38002, USA
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, All Poly Liners, Femoral Components, Total Shoulder Systems, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
www.wmt.com | Send Inquiry | Phone: +1-(901)-867-9971, 800-238-7117
FDA Registration: 3012429289 Year Established: 1950 Annual Revenues: USD 100-500 Million Employee Count: ~1000 Quality: ISO 9002, ISO 9003, CE Certified
Products: Tibial Inserts, Patellar Implants, Metal and Ceramic Liners, All Poly Liners, Femoral Components, Total Shoulder Systems, ...
Wright Medical Technology, Inc. is a global orthopaedic medical device company. Our Advance® Uni-Knee renders normal motion and leads to a longer implant life that delays or prevents the need for more...
Smith & Nephew Inc. | Address: 1450 Brooks Road, Memphis, Tennessee 38116, USA
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
www.smith-nephew.com | Phone: +1-(901)-399-2121, 800-821-5700
Annual Revenues: USD 50-100 Million Employee Count: ~400 Quality: ISO 9001 Certified
Products: Middle Ear Implants, ENT Implants, Ventilation Tubes, AC-Powered Operating Room Table (FDA Code: FQO), AC-Powered Surgical Instrument Motor (FDA Code: GEY), AC-Powered Motor Orthopedic Surgical Instrument (FDA Code: HWE), Abdominal Trocar, ...
Smith & Nephew is a wound care management company that manufactures and supplies medical products for the diagnosis of wound care management. Our products & services for wound, skin, IV, & burn care i more...
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FDA Code / Regulation: HST / 888.5850
A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system.
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 888.9. 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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