BEUDAMED
    Product Code: NBN FDA class 3

    Generator, Shock-Wave, For Pain Relief

    Unknown

    The Shock-Wave Generator for Pain Relief is an orthopedic device that generates and delivers acoustic shock waves to musculoskeletal tissues, used for the treatment of chronic pain conditions such as plantar fasciitis, tendinopathies, and calcific tendinitis. Classified as FDA Class 3, it requires Premarket Approval (PMA) due to the significant risks associated with shock wave treatment for pain management. It is reviewed by the Orthopedic panel.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    NBN
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.