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510(k) Data Aggregation

    K Number
    K140094
    Device Name
    SPRINGTMS TOTAL MIGRAINE SYSTEM
    Date Cleared
    2014-05-21

    (127 days)

    Product Code
    Regulation Number
    882.5808
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENEURA THERAPEUTICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eNeura Therapeutics® Spring TMS® is indicated for the acute treatment of pain associated with migraine headache with aura.
    Device Description
    The SpringTMS® is a portable, hand-held device that delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head to induce an electrical current in a portion of the brain called the occipital cortex to stop or lessen the effects of migraine headaches. Since a single pulse of magnetic stimulation is emitted, this method of stimulation is called single pulse transcranial magnetic stimulation or sTMS. The SpringTMS is indicated for the acute treatment of pain associated with migraine headache with aura. The device is designed for patient use where treatments are selfadministered and can be delivered in a variety of settings including the home or office. The device is intended for prescription use only.
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