# K061912: Fusion

- Pathway: 510(k) (Traditional)
- Applicant: Burke, Inc.
- Decided: Aug 1, 2006 after 26 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 K925122 (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)
- K925122: Pace Saver Little JR, Burke Mobility Products (1994) Summary page 2.
- K965123: Pace Saver, Little Junior (Modification)(Motorized Three-Wheeled Vehicle), Burke, Inc. (1997) Summary page 1.

## Indications for use
Motorized five-wheeled battery powered scooter intended for medical purposes by disabled persons and other non-medical purposes.

Source page: https://510kreport.com/device/K061912
Methodology: https://510kreport.com/methodology