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510(k) Data Aggregation

    K Number
    K222711
    Device Name
    HS186B Scooter
    Manufacturer
    Suzhou Master Machinery Manufacturing Co.,Ltd.
    Date Cleared
    2023-01-09

    (123 days)

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

    Suzhou Master Machinery Manufacturing Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It 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 subject device, Model HS186B Mobility Scooter, is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller, a control panel, an electric motor, an electromagnetic brake, a rechargeable Lithium-lon Battery with a charger. The movement of the scooter is controlled by the rider who operates the throttle Control Lever, speed knob and hand grips. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter is suitable for use indoors and on flat roads near buildings.
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