# K063736: Fuze Mechanical Wheelchair, Models T20 and T50

- Pathway: 510(k) (Traditional)
- Applicant: Pdg Product Design Group, Inc.
- Decided: Jan 17, 2007 after 30 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: 2 generations back to K941989 (1994). 3 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984447: Model Action at II Manual Wheelchair, Invacare Corp. (1999). Our reading of the summary gave K989447, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Invacare Corporations' Action AT II Manual Wheelchair”.

## Most influential descendants
- K152827: Weely Manual Wheelchair (2016), 0 descendants of its own
- K130788: Capella (2013), 0 descendants of its own
- K113164: Discovery Tmax Manual Wheelchair (2013), 0 descendants of its own
- K111636: Rehab TNT, Rehab Ram, Rehab Mac, Rehab Kidster, Bariatric Rehab TNT and Rehab Ram (2012), 0 descendants of its own

## Recalls of this device
- Jun 12, 2012 · Class II · Z-2695-2014: The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use.

## Indications for use
To provide mobility to persons limited to a seated position.

Source page: https://510kreport.com/device/K063736
Methodology: https://510kreport.com/methodology
