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U.S. FDA Medical Device Powered Heating Pad Requirements

FDA Medical Device Definition: A powered heating pad is an electrical device intended for medical purposes that provides dry heat therapy for body surfaces. It is capable of maintaining an elevated temperature during use. Powered_Heating_Unit=

Registrar Corp assists Powered Heating Pad companies with:

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