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U.S. FDA Medical Device Limb Cover 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 Limb Cover companies with:

  • FDA Limb Cover Establishment Registration
  • FDA Limb Cover Listing
  • FDA Limb Cover Label Requirements and Exceptions
  • FDA Limb Cover Import Information
  • FDA Limb Cover Detentions (Limb Cover Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Limb Cover Manufacturers (Limb Cover Suppliers)
       - Limb Cover Distributors
       - Limb Cover Processors
       - Limb Cover Repackers
       - Limb Cover Relabelers
       - Limb Cover Exporters
       - Limb Cover Importers
For more information about Limb Cover 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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