Cables Suppliers
Limit companies to: Worldwide USA
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...
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...
Whiteside Biomechanics, Inc. | Address: 1000 Des Peres Road, Suite 140, St. Louis, Missouri 63131, USA
www.whitesidebio.com | Send Inquiry | Phone: +1-(314)-775-0518, 800-246-6324
Year Established: 1992 Annual Revenues: USD 1-5 Million Quality: ISO 9001, CE Certified
Products: Femoral Components, Acetabular Liners, Revision Femoral Implants, Primary Femoral Implants, Hip Positioner Systems, Osteotomes, ...
Whiteside Biomechanics, Inc. offers a variety of effective hip & knee products. Our quatroloc femoral system is composed of primary, revision and fracture stems to the surgical instrumentation that cr more...
www.whitesidebio.com | Send Inquiry | Phone: +1-(314)-775-0518, 800-246-6324
Year Established: 1992 Annual Revenues: USD 1-5 Million Quality: ISO 9001, CE Certified
Products: Femoral Components, Acetabular Liners, Revision Femoral Implants, Primary Femoral Implants, Hip Positioner Systems, Osteotomes, ...
Whiteside Biomechanics, Inc. offers a variety of effective hip & knee products. Our quatroloc femoral system is composed of primary, revision and fracture stems to the surgical instrumentation that cr more...
EP Medsystems, Inc. | Address: Cooper Run Executive Park, 575 Route 73 North Unit-D, West Berlin, New Jersey 08091, USA
www.epmedsystems.com | Send Inquiry | Phone: +1-(856)-753-8533
Year Established: 1993 Annual Revenues: USD 1-5 Million Employee Count: ~70 Quality: ISO 9000, ISO 9001, CE Certified
Products: Diagnostic EP Consoles, Adjunctive EP Devices, Urological Catheter Care Kits, Catheter Care Kits, Intracardiac Ultrasound Catheter System, Computerized Stimulator, ...
EP Medsystems, Inc. manufactures laboratory products. We focus on the field of electrophysiology. Our ViewMate® system allows clinicians to optimally view the interior of the heart during complex more...
www.epmedsystems.com | Send Inquiry | Phone: +1-(856)-753-8533
Year Established: 1993 Annual Revenues: USD 1-5 Million Employee Count: ~70 Quality: ISO 9000, ISO 9001, CE Certified
Products: Diagnostic EP Consoles, Adjunctive EP Devices, Urological Catheter Care Kits, Catheter Care Kits, Intracardiac Ultrasound Catheter System, Computerized Stimulator, ...
EP Medsystems, Inc. manufactures laboratory products. We focus on the field of electrophysiology. Our ViewMate® system allows clinicians to optimally view the interior of the heart during complex more...
Midmark Corporation | Address: 60 Vista Drive, PO Box 286, Versailles, Ohio 45380-0286, USA
www.midmark.com | Send Inquiry | Phone: +1-(800)-643-6275
FDA Registration: 1523530 Year Established: 1915 Annual Revenues: USD 100-500 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Spirometers, Furniture & Storage, Autoclaves, Instrument Stands, Sterilizing Aids, X-Ray Aids, ...
Midmark Corporation manufactures medical, dental, diagnostic and veterinary products. We are a single-source supplier of a full line of quality healthcare products including power & manual examination more...
www.midmark.com | Send Inquiry | Phone: +1-(800)-643-6275
FDA Registration: 1523530 Year Established: 1915 Annual Revenues: USD 100-500 Million Employee Count: ~500 Quality: ISO 9001, CE Certified
Products: Spirometers, Furniture & Storage, Autoclaves, Instrument Stands, Sterilizing Aids, X-Ray Aids, ...
Midmark Corporation manufactures medical, dental, diagnostic and veterinary products. We are a single-source supplier of a full line of quality healthcare products including power & manual examination more...
Nurse Assist, Inc. | Address: 3400 Northern Cross Blvd., Fort Worth, Texas 76118, USA
www.nurseassist.com | Send Inquiry | Phone: +1-(817)-231-1300, 800-649-6800
FDA Registration: 1650927 Year Established: 1999 Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Irrigating Solutions, Carts, Disposable Syringes, Irrigation Sets & Tubing, IV Catheters & Infusion Sets, General Medical Supplies, ...
Nurse Assist, Inc. is an ISO 13485:2003 certified company. Quantum cables are manufactured with Santoprene™ which is a environmental-friendly plastic rubber that can be incinerated with minimal more...
www.nurseassist.com | Send Inquiry | Phone: +1-(817)-231-1300, 800-649-6800
FDA Registration: 1650927 Year Established: 1999 Annual Revenues: USD 10-25 Million Employee Count: ~80 Quality: ISO 9001, CE Certified
Products: Irrigating Solutions, Carts, Disposable Syringes, Irrigation Sets & Tubing, IV Catheters & Infusion Sets, General Medical Supplies, ...
Nurse Assist, Inc. is an ISO 13485:2003 certified company. Quantum cables are manufactured with Santoprene™ which is a environmental-friendly plastic rubber that can be incinerated with minimal more...
Cascade Orthopedic Supply, Inc. | Address: 2638 Aztec Drive, Chico, California 95928, USA
www.cascade-usa.com | Phone: +1-(530)-879-1500/800-888-0865
FDA Registration: 2950684
Products: Acetabular Liners, Cast Liners, Hip Orthoses, Casting Materials and Equipment, Casting Stands, Post-Operative Hip Orthoses, Pediatric Hip Orthoses, ...
Cascade Orthopedic Supply is a distributor of medical equipment. We focused on prosthetics, orthotistics and foot care specialists. We market ankle joints, cervical, spinal and stirrups. Our new produ more...
www.cascade-usa.com | Phone: +1-(530)-879-1500/800-888-0865
FDA Registration: 2950684
Products: Acetabular Liners, Cast Liners, Hip Orthoses, Casting Materials and Equipment, Casting Stands, Post-Operative Hip Orthoses, Pediatric Hip Orthoses, ...
Cascade Orthopedic Supply is a distributor of medical equipment. We focused on prosthetics, orthotistics and foot care specialists. We market ankle joints, cervical, spinal and stirrups. Our new produ more...
CP Health Inc. | Address: 1365 Logan Ave., Costa Mesa, California 92626-4023, USA
www.medicalcables.com | Send Inquiry | Phone: +1-(714)-641-3395, 800-314-51111
Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Apnea Monitors (FDA Code: FLS), Pediatric Apnea Monitors, Infant Apnea Monitors/alarms, Batteries & Battery Assemblies for Pulse Oximeters, Disposbale Pulse Oximeter Sensors, Neonatal Apnea Monitor (FDA Code: FLS), ...
CP Health Inc. provides bio-medical repair services and medical equipment maintenance. We repair products such as flat screens, autopsy saws, cast cutters, phaco handpieces, vacuum wall regulators and more...
www.medicalcables.com | Send Inquiry | Phone: +1-(714)-641-3395, 800-314-51111
Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9002 Certified
Products: Apnea Monitors (FDA Code: FLS), Pediatric Apnea Monitors, Infant Apnea Monitors/alarms, Batteries & Battery Assemblies for Pulse Oximeters, Disposbale Pulse Oximeter Sensors, Neonatal Apnea Monitor (FDA Code: FLS), ...
CP Health Inc. provides bio-medical repair services and medical equipment maintenance. We repair products such as flat screens, autopsy saws, cast cutters, phaco handpieces, vacuum wall regulators and more...
In Vivo Metric | Address: P.O. Box 397, Healdsburg, California 95448, USA
www.invivometric.com | Send Inquiry | Phone: +1-(707)-433-2949
Year Established: 1965 Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Electrodes and Other Components, Gold Cup Electrodes, Cardiovascular Occluder, Vessel Occlusion Transducer (FDA Code: DXP), Patient Transducer and Electrode Cable (FDA Code: DSA), Cutaneous Electrode (FDA Code: GXY), Composite Surface Biopotential Electrode, ...
In Vivo Metric is a manufacturer of reusable sintered silver-silver chloride electrodes made with 1 mm thick Ag-AgCl sintered sensor mounted in an epoxy ring housing. All parts are firmly encapsulated more...
www.invivometric.com | Send Inquiry | Phone: +1-(707)-433-2949
Year Established: 1965 Annual Revenues: < USD 1 Million Quality: CE Certified
Products: Electrodes and Other Components, Gold Cup Electrodes, Cardiovascular Occluder, Vessel Occlusion Transducer (FDA Code: DXP), Patient Transducer and Electrode Cable (FDA Code: DSA), Cutaneous Electrode (FDA Code: GXY), Composite Surface Biopotential Electrode, ...
In Vivo Metric is a manufacturer of reusable sintered silver-silver chloride electrodes made with 1 mm thick Ag-AgCl sintered sensor mounted in an epoxy ring housing. All parts are firmly encapsulated more...
Physionetics, Llc | Address: #8100 Shaffer Parkway, Suite 130, Littleton, Colorado 80127, USA
www.physionetics.org | Send Inquiry | Phone: +1-(303)-8748274
Products: Prosthetic Devices, Hand Prosthetics, Hand Therapy Grippers, Lower Limb Prosthetics, Pinch Force Dynamometer, Mechanical External Limb Component Hook (FDA Code: IQX), ...
Physionetics, Llc manufactures V2P and I-TAL. Our product, variable pinch-force prehensor features voluntary opening and contains in-line elastics to provide shock absorption and stability. It is prov more...
www.physionetics.org | Send Inquiry | Phone: +1-(303)-8748274
Products: Prosthetic Devices, Hand Prosthetics, Hand Therapy Grippers, Lower Limb Prosthetics, Pinch Force Dynamometer, Mechanical External Limb Component Hook (FDA Code: IQX), ...
Physionetics, Llc manufactures V2P and I-TAL. Our product, variable pinch-force prehensor features voluntary opening and contains in-line elastics to provide shock absorption and stability. It is prov more...
Maguire Enterprises, Inc. | Address: 10289 NW 46th Street, Fort Lauderdale, Florida 33351, USA
www.hackettgroup.org | Send Inquiry | Phone: +1-(954)-572-6000, 800-548-9686
FDA Registration: 1049754 Year Established: 1969 Annual Revenues: USD 1-5 Million
Products: Cables, ECG Cable/Lead, ECG Physiological Telemetry Unit, ECG/EEG Recording Paper, Cables (FDA Code: ISN), Nurse Call Cables, ...
Maguire Enterprises, Inc. is a manufacturer of electronic medical devices. Our products include different types of ECG interconnect cables, output adapters, input adapters, medical device nurse call a more...
www.hackettgroup.org | Send Inquiry | Phone: +1-(954)-572-6000, 800-548-9686
FDA Registration: 1049754 Year Established: 1969 Annual Revenues: USD 1-5 Million
Products: Cables, ECG Cable/Lead, ECG Physiological Telemetry Unit, ECG/EEG Recording Paper, Cables (FDA Code: ISN), Nurse Call Cables, ...
Maguire Enterprises, Inc. is a manufacturer of electronic medical devices. Our products include different types of ECG interconnect cables, output adapters, input adapters, medical device nurse call a more...
Progeny Inc. | Address: 675 Heathrow Drive, Lincolnshire, Illinois 60009, USA
www.progeny-inc.com | Send Inquiry | Phone: +1-(847)-415-9800
FDA Registration: 1423380
Products: X-Ray Collimators, Manual Collimators, Collimators, Radiography & X-ray Spares, Radiography Grids Spares, Radiography & X-ray Accessories, ...
Progeny Inc. provides medical imaging components. We are an ISO 9001 certified company. Our products include collimator, high voltage cable and X-ray accessories. We offer fully automatic and micropro more...
www.progeny-inc.com | Send Inquiry | Phone: +1-(847)-415-9800
FDA Registration: 1423380
Products: X-Ray Collimators, Manual Collimators, Collimators, Radiography & X-ray Spares, Radiography Grids Spares, Radiography & X-ray Accessories, ...
Progeny Inc. provides medical imaging components. We are an ISO 9001 certified company. Our products include collimator, high voltage cable and X-ray accessories. We offer fully automatic and micropro more...
Cosman Company, Inc. | Address: 76 Cambridge St., Burlington, Massachusetts 01803-4140, USA
www.cosmanmedical.com | Send Inquiry | Phone: +1-(781)-272-6561, 888-826-7626
Products: Radiofrequency Equipment, Radiofrequency Lesion Generator (FDA Code: GXD), Radiofrequency Lesion Probe (FDA Code: GXI), Cables (FDA Code: ISN), Radiofrequency Cannulaes, RF Generators, ...
Cosman Company, Inc. specializes in RF generator and electrode technology. Our RF electrode system is ideal for specific applications in the treatment of neurological diseases, pain and cancer. Our pr more...
www.cosmanmedical.com | Send Inquiry | Phone: +1-(781)-272-6561, 888-826-7626
Products: Radiofrequency Equipment, Radiofrequency Lesion Generator (FDA Code: GXD), Radiofrequency Lesion Probe (FDA Code: GXI), Cables (FDA Code: ISN), Radiofrequency Cannulaes, RF Generators, ...
Cosman Company, Inc. specializes in RF generator and electrode technology. Our RF electrode system is ideal for specific applications in the treatment of neurological diseases, pain and cancer. Our pr more...
Lake Region Manufacturing, Inc. | Address: 340 Lake Hazeltine Dr., Chaska, Minnesota 55318-1034, USA
www.lakergn.com | Send Inquiry | Phone: +1-(952)-448-5111
FDA Registration: 2126666 Quality: ISO 9001 Certified
Products: Compact Phacoemulsification Systems, Angioplasty Guidewire, Contract Manufacturing, Angiographic Wire Guide, Cables (FDA Code: ISN), Diagnostic Biliary Catheter (FDA Code: FGE), ...
Lake Region Manufacturing, Inc. is an OEM and contract manufacturer of wire formed medical devices and components. We specialize in minimally invasive devices for cardio, endo and neurovascular applic more...
www.lakergn.com | Send Inquiry | Phone: +1-(952)-448-5111
FDA Registration: 2126666 Quality: ISO 9001 Certified
Products: Compact Phacoemulsification Systems, Angioplasty Guidewire, Contract Manufacturing, Angiographic Wire Guide, Cables (FDA Code: ISN), Diagnostic Biliary Catheter (FDA Code: FGE), ...
Lake Region Manufacturing, Inc. is an OEM and contract manufacturer of wire formed medical devices and components. We specialize in minimally invasive devices for cardio, endo and neurovascular applic more...
Minnesota Wire & Cable Co. | Address: 1835 Energy Park Drive, St Paul, Minnesota 55108, USA
www.mnwire.com | Send Inquiry | Phone: +1-(651)-642 1800
FDA Registration: 2132343 Year Established: 1968 Annual Revenues: USD 10-25 Million Employee Count: ~80
Products: Audiometers (FDA Code: EWO), Audiometers & Accessories, Wires and Cables for Digital Imaging, Wires and Cables for Surgical Lasers, Wires and Cables for Ultrasound, Oxygen Analyzing Cables, ...
Minnesota Wire & Cable Co. produces wire & cable assemblies for the medical, defense, instrumentation and telecommunication industries. We are ISO 13485:2003 & ISO 9001:2001 certified company. Our pro more...
www.mnwire.com | Send Inquiry | Phone: +1-(651)-642 1800
FDA Registration: 2132343 Year Established: 1968 Annual Revenues: USD 10-25 Million Employee Count: ~80
Products: Audiometers (FDA Code: EWO), Audiometers & Accessories, Wires and Cables for Digital Imaging, Wires and Cables for Surgical Lasers, Wires and Cables for Ultrasound, Oxygen Analyzing Cables, ...
Minnesota Wire & Cable Co. produces wire & cable assemblies for the medical, defense, instrumentation and telecommunication industries. We are ISO 13485:2003 & ISO 9001:2001 certified company. Our pro more...
Medisca Inc. | Address: 661 Route 3 Unit C, Beekmantown, New York 12901, USA
www.medisca.com | Send Inquiry | Phone: +1-(800)-9321039
FDA Registration: 3008542820
Products: Gel, Pharmaceuticals, Pharmaceutical Items, Skin Care Creams, Quality Assurance Service, Nutritionals, ...
Medisca Inc. deals with lab devices and equipments. Our products include bases, capsules, chemicals, colors, equipment & devices, essential oils, flavors and nutraceuticals. more...
www.medisca.com | Send Inquiry | Phone: +1-(800)-9321039
FDA Registration: 3008542820
Products: Gel, Pharmaceuticals, Pharmaceutical Items, Skin Care Creams, Quality Assurance Service, Nutritionals, ...
Medisca Inc. deals with lab devices and equipments. Our products include bases, capsules, chemicals, colors, equipment & devices, essential oils, flavors and nutraceuticals. more...
Callcare | Address: 1370 Arcadia Road, Lancaster, Pennsylvania 17601, USA
www.callcareonline.com | Send Inquiry | Phone: +1-(717)-393-9653, 800-345-9414
Year Established: 1989 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Patient Privacy Screens, Nurse Call System, Audio Nurse Call System, Bathroom Grab Bars, Cables (FDA Code: ISN), Bedsheet and Security Clips, ...
Callcare specializes in healthcare products, such as replacement wall stations, nurse call cords, nurse call systems, pillow speakers, wheelchair and safety products, bathroom accessories, shower and more...
www.callcareonline.com | Send Inquiry | Phone: +1-(717)-393-9653, 800-345-9414
Year Established: 1989 Annual Revenues: USD 5-10 Million Employee Count: ~40
Products: Patient Privacy Screens, Nurse Call System, Audio Nurse Call System, Bathroom Grab Bars, Cables (FDA Code: ISN), Bedsheet and Security Clips, ...
Callcare specializes in healthcare products, such as replacement wall stations, nurse call cords, nurse call systems, pillow speakers, wheelchair and safety products, bathroom accessories, shower and more...
Epic Medical Equipment Services, Inc. | Address: 1800 10th St., Suite 300, Plano, Texas 75074, USA
www.epicmedical.com | Send Inquiry | Phone: +1-(972)-801-9854, 800-327-3742
Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Fetal Monitors, Holter Recorder, Disposbale Pulse Oximeter Sensors, Finger Oximeter, Maintenance/Repair Service, Cables (FDA Code: ISN), ...
Epic Medical Equipment Services, Inc. is a provider of pulse oximeters and fetal monitors. We offer finger sensors for pulse oximeters. Our products include pulse oximeter sensors and cables, fetal mo more...
www.epicmedical.com | Send Inquiry | Phone: +1-(972)-801-9854, 800-327-3742
Annual Revenues: USD 5-10 Million Employee Count: ~40 Quality: ISO 9001, CE Certified
Products: Fetal Monitors, Holter Recorder, Disposbale Pulse Oximeter Sensors, Finger Oximeter, Maintenance/Repair Service, Cables (FDA Code: ISN), ...
Epic Medical Equipment Services, Inc. is a provider of pulse oximeters and fetal monitors. We offer finger sensors for pulse oximeters. Our products include pulse oximeter sensors and cables, fetal mo more...
Ludlum Measurements, Inc. | Address: 501 Oak St., Sweetwater, Texas 79556-3209, USA
www.ludlums.com | Send Inquiry | Phone: +1-(325)-235-5494, 800-622-0828
FDA Registration: 1629513 Year Established: 1962 Annual Revenues: USD 10-25 Million Employee Count: ~300 Quality: ISO, CE Certified
Products: Clinical Beta/Gamma Counter (FDA Code: JJJ), Nuclear Spectrometer, Biological Monitor, Probes (FDA Code: HXB), Cables (FDA Code: ISN), Radiation Alarm, ...
Ludlum Measurements, Inc. designs, manufactures and supplies radiation detection & measurement equipment. We have developed radiation detection technologies and instruments in support of enhancing the more...
www.ludlums.com | Send Inquiry | Phone: +1-(325)-235-5494, 800-622-0828
FDA Registration: 1629513 Year Established: 1962 Annual Revenues: USD 10-25 Million Employee Count: ~300 Quality: ISO, CE Certified
Products: Clinical Beta/Gamma Counter (FDA Code: JJJ), Nuclear Spectrometer, Biological Monitor, Probes (FDA Code: HXB), Cables (FDA Code: ISN), Radiation Alarm, ...
Ludlum Measurements, Inc. designs, manufactures and supplies radiation detection & measurement equipment. We have developed radiation detection technologies and instruments in support of enhancing the more...
Biometrics Ltd. | Address: Nine Mile Point Ind. Estate, Unit 25, Cwmfelinfach, Gwent NP11 7HZ, United Kingdom 
www.biometricsltd.com | Send Inquiry | Phone: +44-(1495)-200800
FDA Registration: 8021957
Products: EMG Electrodes, Biofeedback Device (FDA Code: HCC), Powered Exerciser (FDA Code: BXB), AC-powered Goniometer (FDA Code: KQX), Measuring Exerciser (FDA Code: ISD), Non-Measuring Exerciser (FDA Code: ION), ...
Biometrics Ltd. manufactures and distributes sensors, instruments and software for the needs in biomedical & engineering research, clinical rehabilitation and educational settings. Research markets in more...
www.biometricsltd.com | Send Inquiry | Phone: +44-(1495)-200800
FDA Registration: 8021957
Products: EMG Electrodes, Biofeedback Device (FDA Code: HCC), Powered Exerciser (FDA Code: BXB), AC-powered Goniometer (FDA Code: KQX), Measuring Exerciser (FDA Code: ISD), Non-Measuring Exerciser (FDA Code: ION), ...
Biometrics Ltd. manufactures and distributes sensors, instruments and software for the needs in biomedical & engineering research, clinical rehabilitation and educational settings. Research markets in more...
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FDA Code / Regulation: ISN / 890.3420
An external limb prosthetic component is a device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis. Examples of external limb prosthetic components include the following: Ankle, foot, hip, knee, and socket components; mechanical or powered hand, hook, wrist unit, elbow joint, and shoulder joint components; and cable and prosthesis suction valves.
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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