# K071650: C350 Powered Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Permobil AB
- Decided: Sep 12, 2007 after 86 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: 3 generations back to K960951 (1997). 4 ancestors in all.
21 later devices descend from it; 4 cite it directly.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041219: Electro, Permobil AB (2004) Summary page 1.

## Most influential descendants
- K103477: Permobil M300 / M400 (2011), 12 descendants of its own
- K143180: F3 (2015), 9 descendants of its own
- K153543: WHILL Model M (2016), 7 descendants of its own
- K213383: WHILL Model C2 (2021), 6 descendants of its own
- K083017: LEVO C3 (2008), 4 descendants of its own

## Recalls of this device
- 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
- Sep 1, 2017 · Class II · Z-0005-2018: There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.
- Sep 1, 2017 · Class II · Z-0006-2018: There is a potential failure of the top plate assembly, which is the component that connects the seating system of the wheelchair to the base.

## Indications for use
The intended use of the C350 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/K071650
Methodology: https://510kreport.com/methodology