BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P900009 · Supplement: S007 · Decision Aug 25, 1999
    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
    SONIC ACCELERATED FRACTURE HEALING SYSTEM
    PMA Number
    P900009
    Supplement Number
    S007
    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 25, 1999
    Date Received
    July 7, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a name change from SAFHS 2000(R) to Exogen 2000(R). The device is indicated for the acceleration of the time to a healed fracture for fresh*, closed, posteriorly displaced distal radius (Colles') fractures, and fresh*, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopedically managed by closed reduction and cast immobilization. *All fractures in both clinical studies were treated with SAFHS(R) therapy within seven days for fracture.

    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