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

    PIVOT ASSIST

    K Number: K081053 · Decision Oct 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    178

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    Basic Information

    Device Name
    PIVOT ASSIST
    K Number
    K081053
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3110
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pivot Assist, LLC
    Date Received
    April 14, 2008
    Decision Date
    October 9, 2008
    Product Code
    INO
    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
    INO Chair, Positioning, Electric

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