# K050793: Landlex Model S400X

- Pathway: 510(k) (Traditional)
- Applicant: Cycling and Health Tech. Industry R&D Center
- Decided: Jul 7, 2005 after 101 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.
2 later devices descend from it; 2 cite it directly.
0 of 6 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.

## Most influential descendants
- K062646: Ruike, Model 3411 (2007), 0 descendants of its own
- K063196: Landlex, Model S403X (2007), 0 descendants of its own

## Indications for use
The LANDLEX S400X 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/K050793
Methodology: https://510kreport.com/methodology