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510(k) Data Aggregation

    K Number
    K230358
    Device Name
    SAVI Dual (TM) Migraine Therapy
    Manufacturer
    Date Cleared
    2023-05-16

    (95 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 SAVI Dual™ Migraine Therapy device is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults.
    Device Description
    The SAVI Dual Migraine Therapy device 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 SAVI Dual is indicated for the acute and prophylactic treatment of migraine headache in adolescents (age 12 and older) and adults. 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. To use the device, the user must either insert a SIM chip to use the device for a programmed duration or the user may connect wirelessly via a cellular connection for the programmed duration. The programmed duration corresponds to the prescribed months of use.
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