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510(k) Data Aggregation

    K Number
    K061693
    Device Name
    FORYOU POWERED WHEELCHAIR, MODEL FC-100
    Manufacturer
    FORYOU TECHNOLOGY CO., LTD.
    Date Cleared
    2006-07-06

    (21 days)

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

    FORYOU TECHNOLOGY CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
    Device Description
    The WU'S Powered Wheelchair MAMBO 36X is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armirests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembly d for transport and is provided with an onboard battery charger.
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