# K254206: Power wheelchair (ZS-EW8026)

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Zhishan Medical Technology Co., Ltd.
- Decided: Mar 27, 2026 after 88 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: 7 generations back to K023148 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250158: Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003), Zhe Jiang Cleisman Industry and Trade Co.,Ltd (2025) Summary page 6.

## 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/K254206
Methodology: https://510kreport.com/methodology
