BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P050004 · Decision May 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    EMS SWISS DOLORCLAST
    PMA Number
    P050004
    Device Class
    FDA Class 3
    Product Code
    NBN
    Generic Name
    Generator, shock-wave, for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 8, 2007
    Date Received
    February 2, 2005
    Expedited Review
    N
    Docket Number
    07M-0253

    Advisory Committee Statement

    APPROAL FOR THE EMS SWISS DOLORCLAST. THE EMS SWISS DOLORCLAST IS A NON-SURGICAL ALTERNATIVE INDICATED FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS 18 YEARS OF AGE OR OLDER WITH SYMPTOMS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDICAL 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