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U.S. FDA Medical Device Electrical Continence Device Requirements: Electrical Continence Device

FDA Medical Device Definition: A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user

Registrar Corp assists Electrical Continence Device companies with:

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




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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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