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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.

Registrar Corp assists Transverse Rotator companies with:

  • FDA Transverse Rotator Establishment Registration
  • FDA Transverse Rotator Listing
  • 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.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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