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U.S. FDA Medical Device Patient Rotation Bed Requirements


FDA Medical Device Definition: A manual patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation.

Registrar Corp assists Patient Rotation Bed companies with:

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