BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR

    K Number: K910753 · Decision Apr 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    8
    Review Days
    60

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    Basic Information

    Device Name
    FORTRESS MODEL SPIRIT 4-WHEEL POWER WHEELCHAIR
    K Number
    K910753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Fortress Litestyle
    Date Received
    February 21, 1991
    Decision Date
    April 22, 1991
    Product Code
    ITI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITI Wheelchair, Powered

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    Other Clearances by Fortress Litestyle

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    K910752 FORTRESS LIBERTY MANUAL FOLDING WHEELCHAIR
    K910750 FORTRESS CUSTOM MANUAL FOLDING WHEELCHAIR
    K910748 FORTRESS EDGE MANUAL RIGID WHEELCHAIR
    K910746 FORTRESS FREESTYLE II MANUAL FOLDING WHEELCHAIR