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U.S. FDA Medical Device Elastic Stocking 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 Elastic Stocking companies with:

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