# K160835: Titan 3W

- Pathway: 510(k) (Traditional)
- Applicant: Tzora Active Systems, Ltd.
- Decided: Feb 2, 2017 after 314 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 K052204 (2006). 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)
- K150086: Titan, Tzora Active Systems, Ltd. (2015) Summary page 4.

## Indications for use
The Titan 3W is a mobility assistive device for indoor and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

Source page: https://510kreport.com/device/K160835
Methodology: https://510kreport.com/methodology