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Address: 6 Rue De La Redoute, Z.I. Saint-Apollinaire, Dijon Cedex 378333, France
www.orthopaedics.proteor.com |
Phone: +33-(3)-80784210
FDA Registration: 3004134478
Products: Arthroscopic Ankle Joint Distracter, Bone Tongs, Cast Bandage (FDA Code:
ITG), External Brace Hip Joint (FDA Code:
ITS), External Component Thigh Socket Prosthesis (FDA Code:
ISS), External Limb Component Knee Joint (FDA Code:
ISY), ...
Proteor Handicap Technologie markets orthopedic appliances. Our products include prosthetics, orthotics and components for spinal orthoses and seat-braces. We provide feet, knees, ankles, and hip join
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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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Address: 28 Lindsay Ave., Dorval, Quebec H9P 2T8, Canada
www.clearpointdistribution.com |
Send Inquiry |
Phone: +1-(514)-631-7799
Products: Digital Hearing Aids, Implantable Hearing Aids, Hearing Aids, Hearing Aids for Adults, Air Conduction Hearing Aid (FDA Code:
ESD), External Component Thigh Socket Prosthesis (FDA Code:
ISS), ...
Clearpoint International Direct Marketing, Inc. deals with pressure free diabetic socks. The socket improves circulation and non-binding comfort for sensitive feet. It has an extra tall super stretch
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EMAIL INQUIRY to 21 to
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FDA Code / Regulation: ISS / 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.