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U.S. FDA Medical Device Blood Donor Chair Requirements


FDA Medical Device Definition: A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.

Registrar Corp assists Blood Donor Chair companies with:

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