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

    VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &

    K Number: K853992 · Decision Feb 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    27
    Review Days
    147

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    Basic Information

    Device Name
    VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
    K Number
    K853992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Valley Forge Scientific Corp.
    Date Received
    September 27, 1985
    Decision Date
    February 21, 1986
    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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