# K193599: BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: 21st Century Scientific, Inc.
- Decided: Sep 3, 2020 after 255 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: 6 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)
- K092225: Amypower All Track Series Power Wheelchair, Amylior, Inc. (2009) Summary page 5.

## Indications for use
The indication for use of the BOUNDER Power Wheelchair is to provide mobility to persons limited to a sitting position.

Source page: https://510kreport.com/device/K193599
Methodology: https://510kreport.com/methodology