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510(k) Data Aggregation

    K Number
    K250758
    Device Name
    Electric Wheelchair (F309)
    Manufacturer
    CHANGSHU PINGFANG WHEELCHAIR CO., LTD
    Date Cleared
    2025-05-09

    (57 days)

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

    CHANGSHU PINGFANG WHEELCHAIR CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This 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
    The product is intended only carry one person and used as a means of transportation for the disabled, and sick. The electric wheelchair is classified as class B and the maximum occupant mass is 120kg. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle. The wheelchair can easily fold and unfold for transportation or storage.
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