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510(k) Data Aggregation

    K Number
    K070412
    Device Name
    ELEXOMA MEDIC
    Manufacturer
    REDPLANE AG
    Date Cleared
    2008-05-21

    (464 days)

    Product Code
    QJQ, GZJ, JXK
    Regulation Number
    882.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    REDPLANE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes to treat insomnia, depression, or anxiety and The "Elexoma Medic" is a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin for the symptomatic relief of intractable pain, chronic intractable pain, post-traumatic and postsurgical pain relief. The "Elexoma Medic" is a prescription device according to Federal law.
    Device Description
    The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes and a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin.
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