# K012791: C.T.M. Mobility Scooter Model # HS-320

- Pathway: 510(k) (Traditional)
- Applicant: Warepalmy Enterprise, LLC (Usa)
- Decided: Oct 24, 2001 after 65 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: 1 generation back to K923193 (1992). 1 ancestor in all.
42 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923193: Sunrunner TE-777, Pride Health Care, Inc. (1992) Summary page 1.

## Most influential descendants
- K031272: C.T.M. Mobility Scooter, Model HS-120 (2003), 40 descendants of its own
- K032919: C.T.M. Mobility Scooter, Model HS-250 (2003), 37 descendants of its own
- K070603: C.T.M. Mobilitty Scooter # HS-295 (2007), 36 descendants of its own
- K162952: C.T.M. Mobility Scooter (2017), 35 descendants of its own
- K182471: Scooter (2019), 34 descendants of its own

## Indications for use
The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.

Source page: https://510kreport.com/device/K012791
Methodology: https://510kreport.com/methodology