# K250158: Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)

- Pathway: 510(k) (Traditional)
- Applicant: Zhe Jiang Cleisman Industry and Trade Co.,Ltd
- Decided: Apr 28, 2025 after 97 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K023148 (2003). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113463: Power Wheelchair, Suzhou KD Medical Appliance Co., Ltd. (2012) Summary page 5.
- K230964: Power Wheelchair (N5909), Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (2023) Summary page 6.

## Most influential descendants
- K261149: Electric Wheelchair (DY611A-2, DY612A-1) (2026), 0 descendants of its own
- K254206: Power wheelchair (ZS-EW8026) (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/K250158
Methodology: https://510kreport.com/methodology