510(k) K243442
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2025
- Date Received
- November 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Stair Climbing
- Device Class
- Class II
- Regulation Number
- 890.3890
- Review Panel
- PM
- Submission Type
A device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device is intended to climb stairs. 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.