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U.S. FDA Medical Device Unpowered Dialysis Chair Requirements

FDA Medical Device Definition: A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

Registrar Corp assists Unpowered Dialysis Chair companies with:

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