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U.S. FDA Medical Device Pacemaker Charger Requirements

FDA Medical Device Definition: A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.

Registrar Corp assists Pacemaker Charger companies with:

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