BEUDAMED
    Product Code: QAK FDA class 2 21 CFR 882.5892

    Non-Invasive Vagus Nerve Stimulator For Migraine Headache

    Neurology

    The Non-Invasive Vagus Nerve Stimulator for Migraine Headache is a handheld device that delivers non-invasive vagus nerve stimulation (nVNS) on the side of the neck for the treatment or prevention of migraine headache. It is classified as a Class 2 device under regulation 882.5892, requiring 510(k) premarket notification, and falls within the Neurology (NE) medical specialty. The product code is QAK. It is not an implant and is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    QAK
    Device Class
    FDA class 2
    Regulation Number
    882.5892
    Medical Specialty
    Neurology
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat migraine headache.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.