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

    STIMTECH TENS ELECTRODE

    K Number: K790345 · Decision Mar 21, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    STIMTECH TENS ELECTRODE
    K Number
    K790345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Stimulation Technology, Inc.
    Date Received
    February 21, 1979
    Decision Date
    March 21, 1979
    Product Code
    GXY
    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
    GXY Electrode, Cutaneous

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    Other Clearances by Stimulation Technology, Inc.

    K Number Device Name
    K791048 STIMTECH NEUROMUSCULAR STIMULATOR, C 600
    K781565 ELECTRICAL NERVE STIMULATOR MODEL 6035
    K772224 NERVE STIMULATOR, ELEC. TRANSCUTANEOUS
    K770448 INS - T.E.N.S.
    K770447 EPC INSTICKS