BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P900009 · Supplement: S008 · Decision Apr 14, 2000
    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 3000
    PMA Number
    P900009
    Supplement Number
    S008
    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
    April 14, 2000
    Date Received
    October 27, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for various design and manufacturing changes which do not affect the output of the device. The device, as modified, will be marketed under the trade name Exogen 3000.

    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