# K041193: A&I Scooter, SC-402

- 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: 2 generations back to K013763 (2002). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032617: Wu's 4-Wheeled Scooter, WT-L4JR, Wu'S Tech Co., Ltd. (2003) Summary page 1.

## Most influential descendants
- K041677: Karma Scooter, Model KS-747.2 (2004), 1 descendant of its own
- K261232: IERO Mobility Scooter (IERO-01) (2026), 0 descendants of its own

## 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/K041193
Methodology: https://510kreport.com/methodology