# K092154: Heartway Power Mobility Scooter, S9

- Pathway: 510(k) (Traditional)
- Applicant: Heartway Medical Products Co., Ltd.
- Decided: Sep 21, 2009 after 67 days
- Product code: INI (Vehicle, Motorized 3-Wheeled)
- Device class: 2
- Regulation: 21 CFR 890.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032488 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072104: Heartway Power Mobility Scooter, PF6, Heartway Medical Products Co., Ltd. (2007)

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

Source page: https://510kreport.com/device/K092154
Methodology: https://510kreport.com/methodology