# K253762: ErgoSteel (ES0001/696)

- Pathway: 510(k) (Traditional)
- Applicant: Strongback Mobility AG C/O Blueaudit GmbH
- Decided: Sep 22, 2026 after 301 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: 9 generations back to K020472 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231320: Zhenjiang Assure Mechanical Wheelchair,model:K1, Zhenjiang Assure Medical Equipment Co., Ltd. (2023) Summary page 5.

## 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/K253762
Methodology: https://510kreport.com/methodology