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510(k) Data Aggregation

    K Number
    K172270
    Device Name
    gammaCore-2
    Manufacturer
    Date Cleared
    2017-12-07

    (132 days)

    Product Code
    Regulation Number
    882.5892
    Why did this record match?
    Applicant Name (Manufacturer) :

    eletroCore, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The gammaCore-2 Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-2 device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.
    Device Description
    gammaCore-2 is a device that provides non-invasive Vagus Nerve Stimulation (nVNS) when applied to the side of the neck. This is a mild electrical stimulation of the vagus nerve, which runs through the neck and carries information to the central nervous system. Each stimulation with gammaCore-2 lasts two minutes. The patient controls the stimulation strength.
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