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

    NTX100 Tonic Motor Activation (NTX100 ToMAc) System

    K Number: DEN220059 · Decision Apr 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    208

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    Basic Information

    Device Name
    NTX100 Tonic Motor Activation (NTX100 ToMAc) System
    K Number
    DEN220059
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.5887
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Noctrix Health, Inc.
    Date Received
    September 21, 2022
    Decision Date
    April 17, 2023
    Product Code
    QWD
    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
    QWD Stimulator, Nerve, For Restless Legs Syndrome