# K201196: Scooter (Model: FDB01)

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
- Decided: Jun 25, 2021 after 417 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: 7 generations back to K923193 (1992). 10 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182471: Scooter, Tianjin Kepler Vehicle Industry Co., Ltd. (2019) Summary page 4.
- K172440: Solax Electric Scooter, Models: S302121, S302131, S302141, S302151, Dongguan Prestige Sporting Goods., Ltd. (2018) Summary page 4.

## Most influential descendants
- K242982: Mobility Scooter (MS160A) (2025), 1 descendant of its own
- K242387: Mobility Scooter (N3473) (2024), 1 descendant of its own
- K261859: Electric Scooter (FDB08, FDB08A, FDB12) (2026), 0 descendants of its own
- K252275: Electric Scooter (DDF100) (2026), 0 descendants of its own
- K242975: Mobility Scooter (Model X-01, X-02) (2025), 0 descendants of its own

## Indications for use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Source page: https://510kreport.com/device/K201196
Methodology: https://510kreport.com/methodology