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510(k) Data Aggregation

    K Number
    K250134
    Device Name
    Power Wheelchair (YH-E6011,YH-E6013A)
    Date Cleared
    2025-03-26

    (68 days)

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

    Ningbo Youhuan Automation Technology 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, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. The power wheelchair is a battery powered four wheel t consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheels. The operation of the scooter: 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 Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will deternine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the wheelchair uns. 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 the seat will allow for the brakes to engage. When adjusted to the manual model, the assistant can easily push the wheelchair. The power 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.
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    K Number
    K240638
    Device Name
    Power Wheelchair (YH-E7007)
    Date Cleared
    2024-09-16

    (194 days)

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

    Ningbo Youhuan Automation Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The YH-E7007 Power Wheelchair 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. This product is suitable for disabled people with mobility difficulties and elderly people.
    Device Description
    The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. The power 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 controller, Control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels. The operation of the scooter: 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 Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from 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 power 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 Power Wheelchair has 8 inch front wheel and 12 inch rear tire. The motor of power wheelchair is DC24V 250W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/2A. Max. loading can not be over than 120Kgs. Max. distance of travel on the fully charged battery is 20km and Max. speed forward is 6km/h. The braking time is about 2s, and the braking distance is ≤1.5m.
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