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

    CP Relief Wand-OTC

    K Number: K162630 · Decision Dec 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    227
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    CP Relief Wand-OTC
    K Number
    K162630
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5890
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mid-America Medical Innovations, LLC
    Date Received
    September 21, 2016
    Decision Date
    December 20, 2016
    Product Code
    NUH
    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
    NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter

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    Other Clearances by Mid-America Medical Innovations, LLC

    K Number Device Name
    K133779 CP RELIEF WAND