# K223492: eFOLDi Scooter, Lite

- Pathway: 510(k) (Traditional)
- Applicant: Suntech UK, Ltd.
- Decided: Feb 22, 2023 after 93 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: 8 generations back to K923193 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.

## Indications for use
The "eFOLDI Scooter, Lite" 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/K223492
Methodology: https://510kreport.com/methodology