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510(k) Data Aggregation

    K Number
    K221799
    Device Name
    Electric Wheelchair, Model: 9000N
    Date Cleared
    2022-09-16

    (87 days)

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

    Silver Fox Corporation Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electrical Wheelchair (Model: 9000N) is a motor-driven, and indoor transportation vehicle with the intended use to provide mobility to the disabled, the elderly and the infirm for short-distance travel.
    Device Description
    The proposed device, Electrical wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick and adjusting speed. The electrical wheelchair consists of two foldable armrests, a seat cushion, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a Lithium-ion battery, a battery charger, a controller and master module. . Wheelchair frame: Foldable for easy storage and transportation. Controller and Master module: control the forward, steering and speed adjustment of the electric wheelchair. Battery: It was installed at the bottom of the wheelchair. Rear wheel (Driving Wheel): equipped with motor and electric brake device. Front wheel: Provide support to keep the wheelchair stable. The battery of electrical wheelchair is Lithium-ion 24V, 11AH, and the charger is Input: 100-240VAC,50-60Hz, 1.2-0.5A, Output:DC24V,3A The maximum weight limitation of the user is 100kg. This product can be quickly folded, disassembled, and is easy to place in the trunk of a car or lift upstairs. The wheelchair is made of high-quality aluminum alloy. The weight without battery is 23kg. This product is an indoor wheelchair that can be driven indoors or on flat roads near buildings. In principle, it cannot be cross-country. It is not recommended to drive on grass, gravel roads, slopes greater than 12°, and motor vehicle lanes.
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