(134 days)
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 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 manoeuvrable 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 seat, 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. .
- . 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. .
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 jovstick, 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.
I am sorry, but the provided text describes a pre-market notification for a powered wheelchair (Bobcat DX) and does not contain information about acceptance criteria or a study that proves the device meets such criteria. The document is primarily focused on establishing substantial equivalence to a predicate device and outlining the device's features and intended use.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria, device performance, study types, sample sizes, or ground truth establishment.
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).