# K163352: Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Kunshan Hi-Fortune Health Products Co., Ltd.
- Decided: Jul 28, 2017 after 240 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: 10 generations back to K020472 (2002). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153328: SUNCO Mechanical Wheelchair, model SKW-9003, Danyang Sunco Machinery Co., Ltd. (2016) Summary page 6.

## Most influential descendants
- K180852: Manual Wheelchair (2019), 2 descendants of its own
- K220671: Manual Wheelchair (2022), 0 descendants of its own
- K192658: Manual Wheelchair (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K163352
Methodology: https://510kreport.com/methodology