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510(k) Data Aggregation

    K Number
    K990139
    Device Name
    KENSTONE
    Manufacturer
    KENDA USA
    Date Cleared
    1999-04-29

    (100 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENDA USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THIS DEVICE IS A CHAIR WITH LARGE WHEELS WHICH ARE USED TO MOVE AND TURN THE CHAIR BY THE USER. IT CAN BE USED ON A FLAT SURFACE IN A ROOM, A YARD, OR PAVED SURFACE. IT IS ESPECIALLY USEFUL TO THOSE WHO ARE UNABLE TO WALK OR LACK USE OF THEIR LEGS, ALLOWING THE USER A DEGREE OF MOBILITY. THIS CHAIR DOES NOT HAVE A RECLINING FEATURE.
    Device Description
    Mechanical (manual) wheelchair #KE-1M
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