# K050507: Smartech, Model Holi I

- Pathway: 510(k) (Traditional)
- Applicant: Cycling and Health Tech. Industry R&D Center
- Decided: Jul 7, 2005 after 129 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: 2 generations back to K013763 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033239: BE-Mobile 4-Wheeled Electric Scooter, Model DK S500, Tung Keng Enterprise Co., Ltd. (2003) Summary page 2.

## Indications for use
The HOLI I 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/K050507
Methodology: https://510kreport.com/methodology