# K021866: Karma 800 Series Manual Wheelchair

- Pathway: 510(k) (Traditional)
- Applicant: Vestil Manufacturing Corp.
- Decided: Jun 14, 2002 after 8 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- 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 K950395 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950395: Thermocool System, Zimmer, Inc. (1995) Summary page 2.

## Indications for use
THE INTENDED USE OF THE KARMA 800 SERIES MANUAL WHEELCHAIR IS TO PROVIDE MOBILITY TO PERSONS LIMITED TO A SITTING POSITION.

Source page: https://510kreport.com/device/K021866
Methodology: https://510kreport.com/methodology