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510(k) Data Aggregation

    K Number
    K153520
    Device Name
    Electronic Pulse Stimulator
    Manufacturer
    JKH HEALTH CO.,LTD.
    Date Cleared
    2016-05-05

    (149 days)

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

    JKH HEALTH CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS (Modes 1, 2, 4, 5, 6) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, arm, and leg, due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS (Modes 1 and 3) To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
    Device Description
    Not Found
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