# K041187: A&I Scooter, SC-301

- Pathway: 510(k) (Traditional)
- Applicant: Well Success Biotech, Inc.
- Decided: May 25, 2004 after 19 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: 1 generation back to K032488 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032488: Wu's 3-Wheeled Neo Scooter, WT-T3D, Wu'S Tech Co., Ltd. (2003) Summary page 1.

## Indications for use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Source page: https://510kreport.com/device/K041187
Methodology: https://510kreport.com/methodology