Wheelchair, Stair Climbing

FDA product code IMK · Class II (moderate risk) · 21 CFR 890.3890 · Physical Medicine

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.

3510(k) clearances
2PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K243442iBOT® PMDIMK · Traditional Mobius Mobility01/30/2025SE
K210920iBOT Personal Mobility Device (iBOT PMD)IMK · Traditional Mobius Mobility06/16/2021SE
K172601Next Generation iBOTIMK · Traditional Deka Research & Development Corp.03/02/2018SE

PMA approvals

Recalls

RecallProductFirmInitiated
Z-1965-2025 Class IIiBOT PMD with software version 01.05.24. Personal Mobility Device.Software issue that could potentially lead to the device tipping over from Balance Mode. Mobius Mobility LLC04/24/2025Open, Classified
Z-1775-2010 iBOT 4000 Mobility System Battery pack.A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of… Independence Technology LLC02/22/2010Terminated