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510(k) Data Aggregation

    K Number
    K122410
    Device Name
    I RUNE (I-200L)
    Manufacturer
    Date Cleared
    2013-11-12

    (461 days)

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

    MEDIRUNE CO, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    I-RUNE (1-200 L) is to be used 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
    I-RUNE (I-200 L) is a portable pain reliever offering TENS. The channel that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 7modes of operation.
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