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U.S. FDA Medical Device Overhead Supported Arm Sling 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 Overhead Supported Arm Sling companies with:

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