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510(k) Data Aggregation

    K Number
    K202482
    Device Name
    Y207 Electric Wheelchair
    Date Cleared
    2021-03-18

    (202 days)

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

    Jiangsu Intco Medical Products Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Y207 Electric Wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. This product is suitabled people with mobility difficulties and elderly people people.
    Device Description
    This electric wheelchair is a motor driven, indoor and outdoor transportation vehicle, which is a device for assisting elderly and disabled people to be mobile. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of two parts: the electrical part and the wheelchair main body. The electrical part includes motor, battery box, controller and charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, seat and back upholstery. The device is powered by Li-ion Battery pack (24V 20Ah, 480Wh) with 20 Km (12.5 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic intelligent electromagnetic brake system starts to work. Once the joystick is activated again move to other position, the wheelchair will be re-energized.
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