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U.S. FDA Medical Device Patient Transfer Device Requirements


FDA Medical Device Definition: A manual patient transfer device is a device consisting of a wheeled stretcher and a mechanism on which a patient can be placed so that the patient can be transferred with minimal disturbance in a horizontal position to the stretcher.

Registrar Corp assists Patient Transfer Device companies with:

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