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

    FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400

    K Number: K992628 · Decision Oct 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    8
    Review Days
    81

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    Basic Information

    Device Name
    FIRSTCLASS POWER TILT AND RECLINE SEAT SYSTEM, MODEL S400
    K Number
    K992628
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Teftec Corp.
    Date Received
    August 5, 1999
    Decision Date
    October 25, 1999
    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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