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

    INWAVE

    K Number: K121820 · Decision Aug 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    95
    Applicant Total
    5
    Review Days
    64

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    Basic Information

    Device Name
    INWAVE
    K Number
    K121820
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.5320
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zynex Medical, Inc.
    Date Received
    June 21, 2012
    Decision Date
    August 24, 2012
    Product Code
    KPI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KPI Stimulator, Electrical, Non-Implantable, For Incontinence

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    Other Clearances by Zynex Medical, Inc.

    K Number Device Name
    K233485 M-Wave
    K223217 Zynex Monitoring System, Model CM-1600
    K191697 Cardiac Monitor 1500
    K111279 NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM