# K990139: Kenstone

- Pathway: 510(k) (Traditional)
- Applicant: Kenda USA
- Decided: Apr 29, 1999 after 100 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Graham Field Vista Model 31-52005510: named in the summary without a submission number

## Indications for use
THIS DEVICE IS A CHAIR WITH LARGE WHEELS WHICH ARE USED TO MOVE AND TURN THE CHAIR BY THE USER. IT CAN BE USED ON A FLAT SURFACE IN A ROOM, A YARD, OR PAVEB SURFACE. THIS CHAIR DOES NOT HAVE A RECLINING FEATURE. 1T IS ESPECIALLY USEFUL TO THOSE WHO ARE UNABLE TO WALK OR LACK USE OF THEIR LEGS, ALLOWING THE USER A DEGREE OF MOBILITY.

Source page: https://510kreport.com/device/K990139
Methodology: https://510kreport.com/methodology