# K970543: Bobcat DX

- Pathway: 510(k) (Traditional)
- Applicant: Quest Enabling Designs, Ltd.
- Decided: Jun 26, 1997 after 134 days
- Product code: IPL (Wheelchair, Standup)
- Device class: 2
- Regulation: 21 CFR 890.3900
- 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 K942508 (1994). 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)
- K942508: ROBO, Permobil AB (1994) Summary page 1.

## Indications for use
Bobcat DX is highly manoeuvrable, electrically powered wheelchair. The unit consists of a front wheel drive chassis, enclosed in an attractive colourful fibreglass body, that is powered by a Control Dynamics DX microprocessor control unit. This control unit is controlled by a QED designed joystick, which has very sensitive buttons with good tactile feedback. The Bobcat DX comes complete with an elevating seat that allows the child independently to lower themselves to the floor, or to raise themselves to table height. There are many seating options available and we also supply a standing frame. The child can easily adjust both sitting-and standing heights, enabling participation at a table or bar-for meals. Exclusion from normal eating areas and the necessity to have cumbersome trays or special furniture become things of the past. Playing on the floor and outdoors encourages independence for the child, leaving parents and carers free to continue with family socialising and household tasks, knowing that their child can move freely at will. With most activities pressure to assist is reduced merely to supervising normal play and development. The highly manocuvrable Bobcat DX enables children to determine their own activities without asking or waiting for assistance. Simultaneous development, emotional and physical, with their able bodied peer group removes the inevitable frustration which would otherwise set in. Transporting the Bobcat DX presents no difficulty with the easily removable scat, remote drive panel and compact size of the unit. Benefits include: * QED offers a wide range of seating options. ¢ Dynamic DX control system enables the Bobcat DX to be used successfully within the school, home or outdoor. ¢ Three dimensional movement reduces the need for carer participation in many activities. e Easy ‘break-down’ for transport in the back of estate car. ¢ Accessories available including trays, lights and indicators and ramps. ¢ Suitable for users up to 12 stone (75kg) in weight.

Source page: https://510kreport.com/device/K970543
Methodology: https://510kreport.com/methodology
