# K243442: iBOT® PMD

- Pathway: 510(k) (Traditional)
- Applicant: Mobius Mobility
- Decided: Jan 30, 2025 after 85 days
- Product code: IMK (Wheelchair, Stair Climbing)
- Device class: 2
- Regulation: 21 CFR 890.3890
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P020033/S002 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210920: iBOT Personal Mobility Device (iBOT PMD), Mobius Mobility (2021) Summary page 5.

## Recalls of this device
- Apr 24, 2025 · Class II · Z-1965-2025: Software issue that could potentially lead to the device tipping over from Balance Mode.

## Indications for use
The iBOT® Personal Mobility Device ("iBOT® PMD") is intended to provide indoor and outdoor mobility to persons restricted to a sitting position. The device allows for the option to climb stairs. The operator(s), either the wheelchair occupant or an assistant, must meet the requirements of the training certification program. The wheelchair occupant must meet the requirements of the user assessment.

Source page: https://510kreport.com/device/K243442
Methodology: https://510kreport.com/methodology