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U.S. FDA Medical Device Pressure Applying Device Requirements


FDA Medical Device Definition: A presssure-applying device is a device intended for medical purposes to apply continuous pressure to the paravertebral tissues for muscular relaxation and neuro-inhibition. It consists of a table with an adjustable overhead weight that, in place of the therapist's hands, presses on the back of a prone patient.

Registrar Corp assists Pressure Applying Device companies with:

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