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510(k) Data Aggregation

    K Number
    K240255
    Device Name
    Electric Wheelchair (JLE-W01A-2023)
    Manufacturer
    Zhejiang Jianrui Technology Company Limited
    Date Cleared
    2024-08-07

    (189 days)

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

    Zhejiang Jianrui Technology Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    This Electric Wheelchair (JLE-W01A-2023), is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box, charger and anti-tip wheels. The device is powered by Li-ion Battery pack with 27.5 Km range, which can be recharged by an offboard 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 electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized. Anti-tip wheel is a safety device to prevent the wheelchair from turning over when driving on the slope. When the operator needs to use the subject electric wheelchair, he must pull down the anti-tip wheels.
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