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

    INS - T.E.N.S.

    K Number: K770448 · Decision Mar 15, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    436
    Applicant Total
    6
    Review Days
    7

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    Basic Information

    Device Name
    INS - T.E.N.S.
    K Number
    K770448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1320
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Stimulation Technology, Inc.
    Date Received
    March 8, 1977
    Decision Date
    March 15, 1977
    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
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    K772224 NERVE STIMULATOR, ELEC. TRANSCUTANEOUS
    K770447 EPC INSTICKS