# K092650: Heartway Power Mobility Scooter, S12

- Pathway: 510(k) (Traditional)
- Applicant: Heartway Medical Products Co., Ltd.
- Decided: Oct 9, 2009 after 43 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: 4 generations back to K032488 (2003). 4 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K073044: Heartway Power Mobility Scooter, Model PT7, Heartway Medical Products Co., Ltd. (2007)

## Most influential descendants
- K132855: Heartway Power Mobility Scooter (2014), 1 descendant of its own
- K234098: Mobility Scooter (C4+) (2024), 0 descendants of its own
- K133187: FREERIDER FR1, models FR1-13, FR1-15, FR1-17 (2015), 0 descendants of its own

## 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/K092650
Methodology: https://510kreport.com/methodology