U.S. FDA Medical Device Transverse Rotator Requirements
FDA Medical Device Definition: 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.
FDA Transverse Rotator Label Requirements and Exceptions
FDA Transverse Rotator Import Information
FDA Transverse Rotator Detentions (Transverse Rotator Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Transverse Rotator Manufacturers (Transverse Rotator Suppliers)
- Transverse Rotator Distributors
- Transverse Rotator Processors
- Transverse Rotator Repackers
- Transverse Rotator Relabelers
- Transverse Rotator Exporters
- Transverse Rotator Importers
For more information about Transverse Rotator Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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