BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent for Some Indications 🇺🇸 United States

    DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)

    K Number: K864370 · Decision Apr 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    5
    Review Days
    156

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    Basic Information

    Device Name
    DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR)
    K Number
    K864370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Dynatronics Laser Corp.
    Date Received
    November 5, 1986
    Decision Date
    April 10, 1987
    Product Code
    GZJ
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

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