# K252817: Mobility Scooter (BC-MS310)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Baichen Medical Devices Co., Ltd.
- Decided: Jan 2, 2026 after 120 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: 11 generations back to K923193 (1992). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250533: Magnesium alloy scooter (RS100), Taizhou Reach Technology Co., Ltd. (2025) Summary page 5.

## Indications for use
It is 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/K252817
Methodology: https://510kreport.com/methodology
