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510(k) Data Aggregation

    K Number
    K242136
    Device Name
    Electric wheelchair (C001)
    Date Cleared
    2024-09-12

    (52 days)

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

    Zhejiang Hfizer Medical Equipment CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
    Device Description
    The subject Electric wheelchair(C001) is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling. The subject device is intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and outdoor road like flat stone road and so on. The subject device consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable Carbon fiber frame, two armrests, a backrest, a seat cushion, a safety belt, two rear driving wheels(8" / PU solid tire) and two front wheels(6"/ PU solid tire). The electrical part is composed of two motors, two brakes, a lithium battery, a controller and an off-board charger. The device is powered by a Li-ion battery with 14.8km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket when the device is not in use. The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake. The device can convered between electric driving and manual push.
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    K Number
    K240673
    Device Name
    Electric wheelchair
    Date Cleared
    2024-06-20

    (101 days)

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

    Zhejiang Hfizer Medical Equipment CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric 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.
    Device Description
    Electric wheelchair
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    Ask a specific question about this device

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