# K112816: Zhenjiang Asure Mechanical Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.
- Decided: Apr 18, 2012 after 203 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- 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 K020472 (2002). 7 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101999: Kaiyang Steel Wheelchair, Guangdong Kaiyang Medical Technology Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K130017: Valentine Steel Wheelchair (2014), 7 descendants of its own
- K153328: SUNCO Mechanical Wheelchair, model SKW-9003 (2016), 4 descendants of its own
- K163352: Wheelchair (2017), 3 descendants of its own
- K180852: Manual Wheelchair (2019), 2 descendants of its own
- K231320: Zhenjiang Assure Mechanical Wheelchair,model:K1 (2023), 1 descendant of its own

## Indications for use
The device is intended for medical purpose to provide mobility to persons restricted to a sitting position.

Source page: https://510kreport.com/device/K112816
Methodology: https://510kreport.com/methodology