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Address: 561 Division St., Campbell, California 95008, USA
www.hosmer.com |
Phone: +1-(408)-379-5151
Products: Specialty Patient Examination Glove (FDA Code:
LZC), External Ankle Brace (FDA Code:
ITW), External Brace Hip Joint (FDA Code:
ITS), External Brace Knee Joint (FDA Code:
ITQ), External Component Thigh Socket Prosthesis (FDA Code:
ISS), External Limb Component, Ankle/Foot (FDA Code:
ISH), ...
Hosmer Dorrance Corp. specializes in prosthetics. Our Stance flexion device adds adjustable stance flexion to most endoskeletal knee shin systems like weight activated locking knee , single axis frict
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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
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Address: Riverside Orthopaedic Centre, 51 Riverside, Medway City Estate, Rochester, Kent ME2 4DP, United Kingdom
www.rslsteeper.com |
Send Inquiry |
Phone: +44-(1634)-297010
FDA Registration: 9612243
Products: Biofeedback Device (FDA Code:
HCC), Limb Brace Orthosis (FDA Code:
IQI), Mechanical External Limb Component Hand (FDA Code:
IRA), Mechanical External Limb Component Wrist Joint (FDA Code:
ISZ), Powered External Limb Component, Elbow Joint (FDA Code:
IRE), Powered External Limb Component, Hand Joint (FDA Code:
IQZ), ...
RSLSteeper is a provider of clinically effective prosthetic, orthotic and assistive technology care. We provide clinical services and products that enable people to fully realize their potential. We p
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Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com |
Send Inquiry |
Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code:
HTJ), Depth Gauge (FDA Code:
HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code:
HTJ), ENT Forceps (FDA Code:
KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic
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Address: 6a, Baijiazhuang Rd., Beijing Chaoyang District, China
www.ottobock.com |
Send Inquiry |
Phone: +49-(5527)-84814 - 24
FDA Registration: 9611742
Products: Manual Wheelchairs, Wheelchair Accessories (FDA Code:
KNO), Wheelchair Accessories, Amputee Axle Kit, Bariatric Manual Wheelchairs, Disabled/Handicapped Manual Wheelchair (FDA Code:
IOR), Mechanical Wheelchair (FDA Code:
IOR), ...
Otto Bock China provides orthotic, prosthetic and rehabilitation solutions for a wide range of clinical conditions. We offer supportive bracing and soft orthoses, neurostimulation, prostheses & wheelc
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FDA Code / Regulation: IRE / 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.