BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P900009 · Supplement: S018 · Decision Mar 12, 2004
    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 2000+ AND EXOGEN 3000
    PMA Number
    P900009
    Supplement Number
    S018
    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
    March 12, 2004
    Date Received
    January 29, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO DESIGN AND COMPONENT CHANGES: 1) CHANGES TO EXOGEN 2000+ PRINTED CIRCUIT BOARD TO IMPLEMENT CORRECTIVE ACTION FOR FIELD FAILURE AND RETURNS. THIS CORRECTIVE ACTION INVOLVES TWO DESIGN CHANGES: I) REPLACE 2 DIODES ON TE PRINTED CIRCUIT BOARD WITH LIGHT EMITTING DIODES. II) ADD A 1000 PF CAPACITOR TO REDUCE ELECTRICAL NOISE. 2) REPLACE BOTH EXOGEN 2000+ AND EXOGEN 3000 TRANSDUCER CABLES WITH A MORE COST EFFECTIVE MODEL.

    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