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U.S. FDA Medical Device Limb Brace Orthosis Requirements

FDA Medical Device Definition: A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

Registrar Corp assists Limb Brace Orthosis companies with:

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