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

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