FDA Cleared Medical Products

 


We carry FDA cleared medical products meet and exceed all standards for your piece of mind and requirements set by the FDA. All of our power wheelchairs and mobility scooters are FDA cleared. 

We carry mobility products of a variety of styles and brands including EWheels Medical, EV Rider, Shoprider, Merits, Afikim and others. Shop our selection of top rated wheelchairs, mobility scooters and ramps knowing that you are purchasing from a trusted and high quality manufacturers. 

 

FDA cleared products must undergone thorough product testing to ensure safety, durability and performance. This means the manufacturer can demonstrate that their product is "substantially equivalent to another (similar) legally marketed device" that already has FDA clearance or approval

All EWHeels products have passed, and in many cases, exceeded test criteria set forth, assuring the highest level of quality set by the FDA standards and requirements. 

FDA Standards and Requirements

The FDA will verify compliance with the following requirements as applicable: 

  • Registration
  • Listing
  • Certain medical devices may need to comply with Premarket Submission requirements (Premarket Notification or Premarket Approval).
  • The FDA conducts field examinations and analyzes samples of medical devices to ensure they comply with applicable standards and/or label requirements.
  • The FDA checks the import alert database to ensure the manufacturer or product is not subject to detention without physical exam (DWPE) and listed on an import alert. 

FDA verification of medical devices

The FDA entry reviewers are trained to verify compliance with applicable product requirements using the information provided. The FDA uses the internal data systems to verify registration, listing, device approval (when required) or other product requirements and to determine if the firm is subject to DWPE.

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