# K231320: Zhenjiang Assure Mechanical Wheelchair,model:K1

- Pathway: 510(k) (Special)
- Applicant: Zhenjiang Assure Medical Equipment Co., Ltd.
- Decided: Jun 5, 2023 after 28 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: 8 generations back to K020472 (2002). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112816: Zhenjiang Asure Mechanical Wheelchair, Zhenjiang Assure Medical Equipment Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K253762: ErgoSteel (ES0001/696) (2026), 0 descendants 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/K231320
Methodology: https://510kreport.com/methodology