# K080207: Danyang Huayi K2 and K7 Wheelchairs

- Pathway: 510(k) (Traditional)
- Applicant: Danyang Huayi Medical Supply & Equipment Co, Ltd.
- Decided: Mar 12, 2008 after 44 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 K935398 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935398: Tracer Series Manual Wheelchairs, Invacare Corp. (1994) Summary page 2.

## Most influential descendants
- K120526: Yuyue K2 Wheelchair, Yuyue K4 Wheelchair (2012), 0 descendants of its own

## Indications for use
The Danyang Huayi K7 Wheelchair is indicated for providing mobility to persons limited to a sitting position. The Danyang Huayi® K2 Wheelchair is indicated for providing mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K080207
Methodology: https://510kreport.com/methodology