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510(k) Data Aggregation

    K Number
    K122749
    Device Name
    PRESTIGE-MOBIE
    Manufacturer
    PRESTIGE SPORTING GOODS CO. LTD.
    Date Cleared
    2012-12-27

    (111 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRESTIGE SPORTING GOODS CO. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The MOBIE scooter consists of a foldable platform which connects the two front wheels and two rear wheels, an adjustable tiller, a Li-ion battery with an off-board charger, a motor/electromagnetic brake assembly, a electric motor controller and a seat /backrest set. It can be folded for transport in a car trunk. The patient uses the tiller handle/handlebar for steering and a thumb operated potentiometer throttle control lever located at the top of the tiller to engage and disengage the scooter motion in both the forward and reverse directions. When the throttle control lever is released, the electromagnetic brake will be actuated and the scooter is slow to stop.
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