SmartDrive Wheelchair Power Assist
FDA 510(k) K151199 · Max Mobility, LLC
510(k) numberK151199
Submission
- Device name
- SmartDrive Wheelchair Power Assist
- Applicant
- Max Mobility, LLC
Antioch, TN, US - Received
- May 5, 2015
- Decision date
- July 30, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…
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Questions and answers
When was SmartDrive Wheelchair Power Assist cleared by the FDA?
SmartDrive Wheelchair Power Assist (K151199) received a 510(k) decision of Substantially Equivalent on July 30, 2015, 86 days after the submission was received.
What is the product code of K151199?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.