# K082274: Haida Model HD11 Manual Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Jiangyin East China Medical Technology Co., Ltd.
- Decided: Aug 19, 2008 after 8 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: 4 generations back to K941989 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012370: Solara JR. Manual Wheelchair, Invacare Corp. (2001)
- K043332: Wheelchair, Model 8500-II, Cycling and Health Tech. Industry R&D Center (2004) Summary page 1.

## Most influential descendants
- K100824: Mechanical Wheelchair, Model DS 202-S (2010), 0 descendants of its own

## Indications for use
To provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor.

Source page: https://510kreport.com/device/K082274
Methodology: https://510kreport.com/methodology