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510(k) Data Aggregation

    K Number
    K190735
    Device Name
    EQ Balance
    Manufacturer
    Highmark Innovations Inc. DBA Highmark Interactive
    Date Cleared
    2019-08-16

    (148 days)

    Product Code
    LXV
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Highmark Innovations Inc. DBA Highmark Interactive

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EQ Balance is intended to assess body tilt as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. EO Balance should be used in an indoor setting free from obstructions and free from excessive noise or visual distractions. EQ Balance should be only be used as directed by your healthcare practitioner. EQ Balance may be used on mobile devices running iOS or Android operating systems.
    Device Description
    EQ Balance is a mobile balance test to be used on mobile phone and tablet devices with iOS version 10.3 or later, or Android OS version 6 or later. EQ Balance measures balance using the accelerometer within the device. EQ Balance utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device held to the chest by the user. Users follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. EQ Balance does not function as a diagnostic test, and EQ Balance results should be interpreted by qualified individuals only.
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