# K132856: Heartway Power Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Heartway Medical Products Co., Ltd.
- Decided: Jul 15, 2014 after 306 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K022697 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100327: Heartway Power Chair, P23, Heartway Medical Products Co., Ltd. (2010) Summary page 3.

## Indications for use
This device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Source page: https://510kreport.com/device/K132856
Methodology: https://510kreport.com/methodology