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U.S. FDA Medical Device Brace Setting Twister Requirements


FDA Medical Device Definition: An external limb orthotic component is a device intended for medical purposes for use in conjunction with an orthosis (brace) to increase the function of the orthosis for a patient's particular needs. Examples of external limb orthotic components include the following: A brace-setting twister and an external brace stirrup.

Registrar Corp assists Brace Setting Twister companies with:

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