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    K Number
    K160893
    Device Name
    HANAROCare ReJu
    Manufacturer
    M.I.TECH CO.,LTD
    Date Cleared
    2016-07-27

    (118 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    M.I.TECH CO.,LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HANAROCare ReJu is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    HANAROCare ReJu is a personal stimulator that reduces the pain by delivering a specific rhythmic electric stimulation to the nerves and the muscles through electrode attached to the skin (Transcutaneous Electrical Nerve Stimulation). Electric current delivered to the nerves reduces the pain. The subject device offers four different stimulation modes (Mode 1, Mode 2, Mode 3, and Combination Mode). It is composed of as stimulator, silicon electrode, and gel pads.
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