# K040561: Manual Wheelchair Series

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Wheelchair Factory
- Decided: Mar 31, 2004 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: 1 generation back to K930803 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930803: Action Patriot Manual Wheelchair, Invacare Corp. (1994) Summary page 2.
- K974820: Breezy Series, Sunrise Medical, Inc. (1998) Summary page 2.

## Indications for use
The intended use of the Manual Wheelchair Series is to provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K040561
Methodology: https://510kreport.com/methodology