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Address: 2030 N. Forbes Blvd., #106, Tucson, Arizona 85745, USA
Phone: +1-(520)-623-9800
Products: Knee Braces, Knee Braces & Supports, External Brace Knee Joint (FDA Code:
ITQ), Limb Brace Orthosis (FDA Code:
IQI), Orthotic/Prosthetic Monitor (FDA Code:
NHF), ...
Armor Sports Holdings, LLC provides air armor leg protection system, knee brace, and prophylactic knee brace.
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Address: 19 Cortland Drive, Hudson, Massachusetts 01749, USA
www.touchbionics.com |
Phone: +1-(614)-388-8075
FDA Registration: 3008018840
Products: Orthotic/Prosthetic Monitor (FDA Code:
NHF), ...
Touch Bionics Inc. is a provider of prosthetic solutions. Our ProDigits&trade are prosthetic digits which are self-contained fingers that are individually powered and controlled to provide new fingers
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Address: 116 N. Tennessee, Suite 203, Mckinney, Texas 75069, USA
Phone: +1-(214)-4328991
Products: Cast Covers (FDA Code:
KIA), Bedpan (FDA Code:
FOB), Orthotic/Prosthetic Monitor (FDA Code:
NHF), ...
Nu-Idears, Inc. deals with bedpan, cast covers and orthotic & prosthetic monitors.
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Address: 6405 218th Ave. Sw, Suite 100, Mountlake Ter, Washington 98043, USA
www.orthocareinnovations.com |
Phone: +1-(425)-771-0797
FDA Registration: 3013413460
Products: Prosthesis, Prosthetic Lower Extremity Kits, Upper Extremity Orthoses, Isokinetic Testing and Evaluation System (FDA Code:
IKK), Orthotic/Prosthetic Monitor (FDA Code:
NHF), ...
Orthocare Innovations, LLC is a medical device research and product development company. Our products are Compas™, Smart Pyramid™ and StepWatch™. The Compas is a computerized prosthe
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Address: , Canada
https://www.solescience.ca |
Send Inquiry |
Phone: +1-(844)-337-7653
Products: Flexible Orthotics, Custom Orthotics, Diasole Orthotics, Finger Orthotic Devices, Elbow Orthotic Devices, Custom Orthotics Insoles, ...
SoleScience specializes in providing custom orthotics. We believe that proper foot orthotics are an important factor in maintaining proper foot health. We are believers of the Soft Tissue Stress theor
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Address: Moosfeldstrasse 10, Emmering, Bavaria 82275, Germany
www.streifeneder.de |
Phone: +49-(813)-2465995
Quality: EN ISO 13485 and EN ISO 9001 Certified
Products: Medical Insoles (FDA Code:
KYS), Cast Component (FDA Code:
LGF), Cast Bandage (FDA Code:
ITG), Mechanical External Limb Component Elbow Joint (FDA Code:
IRD), Prosthesis Valve (FDA Code:
ISP), Orthotic/Prosthetic Monitor (FDA Code:
NHF), ...
F.G. Streifeneder Kg is a supplier and manufacturer of orthopedic products. The broad product range and the variety of modern materials is an ideal solution for the specific demands of each patient. W
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FDA Code / Regulation: NHF / 890.3025 A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
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.