# K240008: Mobility Scooter (W3331)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
- Decided: Jun 5, 2024 after 155 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.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222495: Mobility Scooter, Model: W3331F, Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (2022) Summary page 5.

## Most influential descendants
- K250533: Magnesium alloy scooter (RS100) (2025), 1 descendant of its own
- K253600: Scooter (YD-03) (2026), 0 descendants of its own
- K252817: Mobility Scooter (BC-MS310) (2026), 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/K240008
Methodology: https://510kreport.com/methodology