# K090735: C.T.M. Mobility Scooter, HS-528

- Pathway: 510(k) (Traditional)
- Applicant: C.T.M. Homecare Product, Inc.
- Decided: Jul 6, 2009 after 109 days
- Product code: INI (Vehicle, Motorized 3-Wheeled)
- Device class: 2
- Regulation: 21 CFR 890.3800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930952 (1994). 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)
- K071949: Victory, 4 Wheel Scooter / Model, # SC1740, Pride Mobility Products Corp. (2007) Summary page 1.

## Recalls of this device
- Dec 7, 2011 · Not classified · Z-0774-2012: Invacare Corporation decided to recall the products because the scooter backrest fails unexpectedly due to seat flexing, and this has the potential to result in a consumer falling causing death or ser

## Indications for use
The C.T.M. Mobility Scooter HS-528 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

Source page: https://510kreport.com/device/K090735
Methodology: https://510kreport.com/methodology