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510(k) Data Aggregation

    K Number
    K130982
    Device Name
    LERADO, POWER WHEELCHAIR
    Date Cleared
    2014-02-28

    (325 days)

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

    LERADO GLOBAL (MACAO COMMERCIAL OFFSHORE) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    LERADO, Powered Wheelchair, DF4110 series include the devices with the same mechanic and electric controlling structure but with different colors of body and veneer. The LERADO Powered Wheelchair, DF4110 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat and is battery operated. The device can be disassembled for transportation, easily foldable and is provided with an off-board battery charger. The movement of the wheelchair is controlled by the rider who uses hand controls located at the top of the steering column.
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