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510(k) Data Aggregation

    K Number
    K171071
    Device Name
    StimSox(TM) System
    Manufacturer
    Date Cleared
    2017-08-09

    (121 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    StimMed, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The StimSox™ System is indicated to temporarily increase local blood circulation in healthy leg muscles and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
    Device Description
    The StimSox™ System is comprised of a battery powered electrical stimulator, disposable gel electrodes, two left foot boots, two right foot boots, and three AAA batteries.
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    K Number
    K151922
    Device Name
    StimSox(TM) System
    Manufacturer
    Date Cleared
    2016-04-15

    (277 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    StimMed, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To temporarily increase local blood circulation in healthy leg muscles.
    Device Description
    The StimSox™ System is comprised of a battery powered electrical stimulator, disposable gel electrodes, two left foot boots, two right foot boots, three AAA batteries and user manual. The StimSox™ Stimulator software is embedded firmware written for a microcontroller. The software in the StimSox™ Stimulator is for input controls and output display. There is no operating system. It is a real-time loop that is event driven based on the three buttons on the box.
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