# K080385: Cruiser PP5500 Challenger Powered Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: E1 Ent., Inc.
- Decided: May 13, 2008 after 90 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K900565 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021680: Invacare Powered Wheelchairs, Models M50, M51, M71 & M91, Invacare Corp. (2002) Summary page 1.

## Indications for use
To provide enhanced mobility to physically challenged persons limited to a sitting position.

Source page: https://510kreport.com/device/K080385
Methodology: https://510kreport.com/methodology