# K180309: Manual Wheelchair W54

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Jumao Medical Equipment Co., Ltd.
- Decided: May 3, 2019 after 455 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: 6 generations back to K020472 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170517: Merits Model R106/R136 Rehab Wheelchair, Merits Healthcare Industries (Suzhou) Co., Ltd. (2017) Summary page 4.
- K151797: Nuocande Plastic Manual Wheelchair Model NKD L07, Ningbo Lecount Medical Technology Co., Ltd. (2015) Summary page 4.

## Indications for use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. It is designed for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and pocked dirt) that are free of large obstacles and inclines greater than 6 degrees.

Source page: https://510kreport.com/device/K180309
Methodology: https://510kreport.com/methodology