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

    MICROSTIM 100I TENS DEVICE

    K Number: K010295 · Decision Aug 3, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    184
    Registration Numbers
    184
    Same Product Code
    605
    Applicant Total
    2
    Review Days
    184

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    Basic Information

    Device Name
    MICROSTIM 100I TENS DEVICE
    K Number
    K010295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Microstim, Inc.
    Date Received
    January 31, 2001
    Decision Date
    August 3, 2001
    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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    Other Clearances by Microstim, Inc.

    K Number Device Name
    K910580 MICROSTIM 100 MODEL 2C