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

    M-Wave

    K Number: K233485 · Decision Jan 26, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    M-Wave
    K Number
    K233485
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zynex Medical, Inc.
    Date Received
    October 27, 2023
    Decision Date
    January 26, 2024
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Zynex Medical, Inc.

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    K223217 Zynex Monitoring System, Model CM-1600
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