# K062645: Ruike, Model 3431

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Ruike Sports Goods Co., Ltd.
- Decided: Dec 19, 2006 after 104 days
- Product code: INI (Vehicle, Motorized 3-Wheeled)
- Device class: 2
- Regulation: 21 CFR 890.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K013763 (2002). 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)
- K043326: Bewell, Model SC 20, Cycling and Health Tech. Industry R&D Center (2005) Summary page 1.

## Indications for use
The Ruike 3431 scooter 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/K062645
Methodology: https://510kreport.com/methodology