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

    FACTS HAND AND PINCH GRIP COMBO

    K Number: K073154 · Decision Feb 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    98

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    Basic Information

    Device Name
    FACTS HAND AND PINCH GRIP COMBO
    K Number
    K073154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1240
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Global Services Group, LLC
    Date Received
    November 8, 2007
    Decision Date
    February 14, 2008
    Product Code
    LBB
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LBB Dynamometer, Ac-Powered

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