# K111636: Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT and Rehab Ram

- Pathway: 510(k) (Traditional)
- Applicant: Gunnell, Inc.
- Decided: Apr 3, 2012 after 295 days
- Product code: IOR (Wheelchair, Mechanical)
- Device class: 1
- Regulation: 21 CFR 890.3850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K941989 (1994). 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)
- K971389: Eclipse 400 Manually Operated Wheelcair, Pdg Product Design Group, Inc. (1997) Summary page 1.
- K990557: The Stellar Tilt, Manually Operated Wheelchair, Pdg Product Design Group, Inc. (1999) Summary page 1.
- K961743: Eclipse 600 Manually Operated Wheelchair, Pdg Product Design Group, Inc. (1996) Summary page 1.
- K080270: Manual Rigid Mobility Wheelchair, Freedom Designs, Inc. (2008) Summary page 1.
- K063736: Fuze Mechanical Wheelchair, Models T20 and T50, Pdg Product Design Group, Inc. (2007) Summary page 1.

## Recalls of this device
- Jan 18, 2013 · Class II · Z-0809-2013: The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on the Gunnell Rehab Series of Wheelchairs (GR

## Indications for use
The intended use of all of the GRSW’s is to provide mobility to individuals restricted to a sitting position.

Source page: https://510kreport.com/device/K111636
Methodology: https://510kreport.com/methodology