# K123290: M300 & M400

- Pathway: 510(k) (Traditional)
- Applicant: Permobil AB
- Decided: Apr 17, 2013 after 177 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960951 (1997). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071650: C350 Powered Wheelchair, Permobil AB (2007) Summary page 1.

## Most influential descendants
- K202632: Electric wheelchair (S7204/S7205) (2021), 0 descendants of its own
- K140706: Levo Max (2015), 0 descendants of its own

## Recalls of this device
- Jun 19, 2025 · Class II · Z-2805-2026: This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an uns
- Feb 29, 2024 · Class II · Z-2795-2026: This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the w
- Aug 15, 2018 · Class II · Z-3178-2018: This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back le

## Indications for use
The intended use of the M300 & M400 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair.

Source page: https://510kreport.com/device/K123290
Methodology: https://510kreport.com/methodology