# K252275: Electric Scooter (DDF100)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Nysin Medical Co., Ltd.
- Decided: Jan 29, 2026 after 191 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: 9 generations back to K923193 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201196: Scooter (Model: FDB01), Nanjing Jin Bai HE Medical Apparatus Co., Ltd. (2021) Summary page 5.
- K242982: Mobility Scooter (MS160A), Suzhou Master Machinery Manufacturing Co.,Ltd (2025) Summary page 5.

## Indications for use
The electric scooter 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/K252275
Methodology: https://510kreport.com/methodology