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510(k) Data Aggregation

    K Number
    K242402
    Device Name
    Power wheelchair
    Date Cleared
    2024-11-18

    (97 days)

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

    Zhejiang Zhonglei Medical 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
    Not Found
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    K Number
    K241686
    Device Name
    Power wheelchair (N6101)
    Date Cleared
    2024-08-13

    (62 days)

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

    Zhejiang Zhonglei Medical 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
    whole wheelchair can be folded by one button and it can be easily carried or rolled after folding type:left-right folding). The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The crive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are solid polyurethane tires. When in use, the operator drives the motor of the rear wheel by operating the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 136KG. Only for one person sit.
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