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U.S. FDA Medical Device Temporary Training Splint 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 Temporary Training Splint companies with:

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