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510(k) Data Aggregation

    K Number
    K182267
    Device Name
    PAT (Pain Alleviation Technologies)
    Manufacturer
    Marchan Medical, LLC
    Date Cleared
    2019-02-27

    (190 days)

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

    Marchan Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Temporary relief of pain associated with sore and aching muscles and joints due to strain from exercise or normal household and work activities.
    Device Description
    PAT is an OTC medical device. This device is used for temporary relief of pain of sore and aching muscles and joints, due to strain from exercise or normal household and work activities. The device consists of a small battery operated enclosure with an LCD screen and user buttons to control the device. A monophasic micro-current waveform is transmitted to the affected body part through a cable connected via snaps to skin surface electrodes. There are 8 non-programmable modes representing 8 different body areas to treat.
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