BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

    PMA: P900009 · Supplement: S027 · Decision Aug 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
    Trade Name
    EXOGEN 4000+BONE HEALING SYSTEM
    PMA Number
    P900009
    Supplement Number
    S027
    Device Class
    FDA Class 3
    Product Code
    LPQ
    Generic Name
    Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 16, 2007
    Date Received
    July 10, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN INTERNAL DEVICE CIRCUITRY AS MITIGATION AGAINST KNOWN DEVICE FAILURE MECHANISMS WHICH DO NOT IMPACT UPON ULTRASOUND OUTPUT OR SIGNAL PARAMETERS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep