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U.S. FDA Medical Device Recreational Adaptor Requirements

FDA Medical Device Definition: A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.

Registrar Corp assists Recreational Adaptor companies with:

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