# K041219: Electro

- Pathway: 510(k) (Traditional)
- Applicant: Permobil AB
- Decided: Aug 4, 2004 after 86 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K960951 (1997). 3 ancestors in all.
22 later devices descend from it; 1 cites 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)
- K991658: Permobil Powered Wheelchair 1280, Permobil AB (1999) Summary page 1.

## Most influential descendants
- K071650: C350 Powered Wheelchair (2007), 21 descendants of its own
- 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

## 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.
- Feb 21, 2012 · Not classified · Z-1278-2012: The fasteners used between June 3, 2011 and January 31, 2012 to attach the Permolock C3 pins to wheelchairs manufactured in the United States do not contain the required nylon ring, which allows for a

## Indications for use
The intended use of the Electro 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/K041219
Methodology: https://510kreport.com/methodology