# K091418: C.T.M. Mobility Scooter, Model HS-628, Invacare Orion

- Pathway: 510(k) (Traditional)
- Applicant: C.T.M. Homecare Product, Inc.
- Decided: Jul 6, 2009 after 54 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: 2 generations back to K003059 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030387: C.T.M. Mobility Scooter, Model HS-890, C.T.M. Homecare Product, Inc. (2003)

## Indications for use
The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Source page: https://510kreport.com/device/K091418
Methodology: https://510kreport.com/methodology