FDA Cleared Medical Products
EWheels Medical products meet and exceed all standards for your piece of mind and requirements set by the FDA. All of EWheels power wheelchairs and mobility scooters are FDA cleared.
All EWheels Medical products have undergone thorough product testing to ensure safety, durability and performance. Our power chairs, and scooters are Food & Drug Administration (FDA) approved medical products that require specific testing prior to release for public use.
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:
- 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.