(187 days)
Mobility assistive device for indoor use and outdoor usc on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.
The Elite Scooter is a mobility assistive device for indoor use and outdoor use on mild terrain. The Elite Scooter is an ultra-light, compact, portable vehicle. It is designed for the use of active individuals that are able to walk short distances, but need assistance. The user must have sufficient arms and legs strength to get on and off the Elite on his/her own and to steer without effort under all driving conditions. The maximum allowed weight of the user is 250 lbs. The Elite features the patented Wheel Drive system that incorporates the motor in the front wheel for additional ease of steering. The innovation is restricted to the modification of the design and construction of the hub type magnet brush pancake motor and drive unit. The Elite has the following main components: The Foldable rear frame and the Steering column made from steel tubular welded parts with an oven baked powder coated paint finish. A single drive wheel and two free turning rear wheels. All three wheels are solid. The front wheel size is 10"x2", the rear wheel size is 8"x2". The seat is made from two Polypropylene injected molded vinyl covered foam. The backrest folds down and latches for transportation. The seat is adapted and fitted to the foldable rear-frame. The front wheel drive with a DC permanent magnet brush pancake motor. Because the reduction gear is a spur gear and not worm gear it is a very efficient system. The hub assembly, comprises the drive wheel, pancake shaped PM dc motor, reduction gearbox and an electro-magnetic brake. It has a slick structure, compact dimensions, high efficiency and low noise. It has no moving parts; is fixed to the front fork of the Elite. An electro-magnetic brake connected to its rear shaft. The brake is released electrically by the controller during motor operation, and applied after the motor decelerates and comes to a stop. A mechanical spring automatically applies the brake in case of an electrical failure. The control is a forward/reverse wigwag type that can be operated by both left and right hand. A speed adjustment knob limits the maximum speed. There is a Power On/Off key switch on the control panel, a battery gauge and a LED for low battery and fault condition indication. The brake release toggle is on the control cover. The Controller from Penny and Giles Drives Technologies Ltd. (UK), conforms to all applicable international standards. The 12V battery packs are available in two sizes: the Mini-size pack contains 7.2Ah capacity batteries and the Jumbo size pack -- 12Ah capacity. There is a short-circuit protection fuse in the Battery Pack. The 100-240 VAC charger charges the batteries either directly (off board) or via a socket on the front column with an inhibit feature that does not allow the scooter to be driven when the batteries are being charged. Carrying Basket placed below the seat.
The provided text is a 510(k) summary for "The Elite - ultra-light, compact portable scooter". It describes the device, its components, and its intended use. However, this document does not contain information regarding acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication), or MRMC/standalone study results.
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§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).