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510(k) Data Aggregation

    K Number
    K242791
    Device Name
    Electric wheelchair (KR-8807)
    Date Cleared
    2024-11-12

    (57 days)

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

    Zhejiang Kairui Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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, Electric Wheelchair, mainly powered by DC motor, driven by user controlling joystick controller and adjusting speed. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Rear wheels. The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the loystick can control the wheelchair to travel in any direction, the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electic Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling. The Electric Wheelchair has 7 inch front wheels and 12 inch rear tires. Max. distance of travel on the fully charged battery is 15 km and Max. speed forward is 6.5 km/h. When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate to lock the motor, so as to brake.
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