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U.S. FDA Medical Device Reuseable Hot or Cold Pack Requirements


FDA Medical Device Definition: A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.

Registrar Corp assists Reuseable Hot or Cold Pack companies with:

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