# K070501: Ruike 3421 Powered Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Ruike Sports Goods Co., Ltd.
- Decided: Mar 22, 2007 after 29 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K023148 (2003). 2 ancestors in all.
73 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062888: Middle Wheel Drive Power Chair, CWD01, Emg Technology Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K113463: Power Wheelchair (2012), 71 descendants of its own
- K220747: Power Wheelchair (N5515B) (2022), 37 descendants of its own
- K231508: Power Wheelchair, W5521 (2023), 8 descendants of its own
- K230964: Power Wheelchair (N5909) (2023), 7 descendants of its own
- K163204: A08 Power wheelchair (2017), 7 descendants of its own

## Indications for use
The Ruike 3421 powered wheelchair is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Source page: https://510kreport.com/device/K070501
Methodology: https://510kreport.com/methodology