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

    KINESIA

    K Number: K063872 · Decision Apr 6, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    98

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    Basic Information

    Device Name
    KINESIA
    K Number
    K063872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cleveland Medical Devices, Inc.
    Date Received
    December 29, 2006
    Decision Date
    April 6, 2007
    Product Code
    GYD
    Advisory Committee
    Neurology
    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
    GYD Transducer, Tremor

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