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510(k) Data Aggregation

    K Number
    K182976
    Device Name
    SpringTMS
    Manufacturer
    Date Cleared
    2019-02-25

    (122 days)

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

    eNeura® Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eNeura Inc. SpringTMS® is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.
    Device Description
    The SpringTMS® is a portable, hand-held device that is designed and intended to deliver 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 and prophylactic treatment of migraine headache. The device is designed for patient use where treatments are self-administered 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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