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    K Number
    K241588
    Device Name
    Electric Wheelchair (KR8803)
    Date Cleared
    2024-11-25

    (175 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
    The "Electric Wheelchair, Model: KR8803" 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 Electric Wheelchair (Model: KR8803) is a motor-driven, and indoor/outdoor electric transportation vehicle that is intended to be used by individuals that are disabled or elderly for short distance travel. It has a base with Aluminum alloy frame, two front wheels, two rear wheels, two anti-tippers, two arm rests, one seat, one backrest frame with push handle, two brushed DC motor. One driver and one controller, one lower leg support assemblies, one foot support, electromagnetic braking system, steering mechanisms and one rechargeable Li-ion battery with an off-board charger. The movement of the wheelchair is controlled by the occupant or assistant who operates the controller (joystick). The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The device only can be operated on the flat road. The Electric Wheelchair has a physical dimension of 105 (depth) x 60 (width) x 99 (height) cm. with the seat itself has a dimension of 44.5 (depth) x 45 (width) x 42 (height) cm. The footrest is 9.5 cm in height. The device is foldable, and the folded dimension is 60 (Long) x 39.5 (width) x 80 (height) cm. The Electric Wheelchair has a maximum weight capacity of 120 kilograms, and weighs about 26.68 kilograms with battery (23.5 kilograms without battery). The color is black. The Electric Wheelchair consists of four wheels, a mechanical main frame, seat, backrest frame with push handle, and mesh fabric upholstery that is ignition resistant. The frame of the device is made of aluminum alloy. The Electric Wheelchair uses aluminum alloy wheels and the back wheel has a diameter of 25.4 cm (12 inch) and the front wheel has a diameter of 20.3 cm (8 inch). Both front wheels use solid tires and the back wheels are pneumatic tires. The Electric Wheelchair has a motor of 24V and 250 Watt, which allows a maximum speed of 5.2 kilometers per hour, and maximum travel range of 20 kilometers. The wheel lock is in the form of electromagnetic force to apply mechanical resistance to the rear wheels to force stop.
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    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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