BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P040026 · Decision Apr 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE
    PMA Number
    P040026
    Device Class
    FDA Class 3
    Product Code
    NBN
    Generic Name
    Generator, shock-wave, for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Physical Medicine
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 1, 2005
    Date Received
    June 4, 2004
    Expedited Review
    N
    Docket Number
    05M-0241

    Advisory Committee Statement

    APPROVAL FOR THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY DEVICE. THE DEVICE IS INDICATED FOR THE TREATMENT OF PROXIMAL PLANTAR FASCIITIS WITH OR WITHOUT HEEL SPUR IN PATIENTS 18 YEARS OF AGE OR OLDER. THE ORTHOSPEC EXTRACORPOREAL SHOCK WAVE THERAPY IS A NON-INVASIVE ALTERNATIVE METHOD FOR PATIENT WITH SYMPTOMS OF PROXIMAL PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPIES TO RELIEVE HEEL PAIN. PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE PLANTAR CALCANEAL TUBEROSITY.

    Classifications

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

    Product Code Device Name
    NBN Generator, Shock-Wave, For Pain Relief