# K080114: Huayi H035 Basic Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Danyang Huayi Medical Supply & Equipment Co, Ltd.
- Decided: Feb 15, 2008 after 30 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: 2 generations back to K002669 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050280: Runabout Wheelchair, Access Point Medical, LLC (2005) Summary page 2.

## Most influential descendants
- K120077: Comed K-Series Manual Wheelchair (2012), 0 descendants of its own

## Indications for use
The Danyang Huayi® H035 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K080114
Methodology: https://510kreport.com/methodology