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510(k) Data Aggregation

    K Number
    K170787
    Device Name
    Powered Wheelchair DYW30A(D09)
    Manufacturer
    Nanjing Jin Bai He Medical Apparatus Co., Ltd.
    Date Cleared
    2017-08-09

    (146 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nanjing Jin Bai He Medical Apparatus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to a disabled or an elderly person limited to a seated position.
    Device Description
    The powered wheelchair DYW30A(D09) is driven by two DC motors, and is suitable for indoor uses. It is an individual transportation vehicle for disabled and elderly people that experience difficulties in walking. The powered wheelchair DYW30A(D09) comes as preassembled, designed to be lightweight, easily maneuvered, highly portable, and most importantly, safe and comfortable. It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. The device is powered by two 12 volt / 6 Ah Lithium-ion batteries with 11.2 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz), when the device is not in use. The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of DYW30A(D09) is 264 lbs and its maximum speed is 3.75 mph.
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