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510(k) Data Aggregation

    K Number
    K131956
    Device Name
    QUICK RELAX PRO
    Date Cleared
    2014-04-24

    (301 days)

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

    HEALTHCARE INNOVATIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    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
    Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.
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