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510(k) Data Aggregation

    K Number
    K183661
    Device Name
    ClearEdge Balance System
    Manufacturer
    Quadrant Biosciences
    Date Cleared
    2019-10-22

    (299 days)

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

    Quadrant Biosciences

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearEdge® Balance System is intended for use to assess sway 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, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
    Device Description
    The ClearEdge® Balance System is a mobile software system that analyzes balance through measurements of postural sway. The System is comprised of application software, and accompanying hardware consisting of a mobile computing device, proprietary sensor, balance pad, and friction pad. The test data is collected, uploaded to a HIPAA compliant server, analyzed by Motion Intelligence developed algorithms and presented in report form for clinician's review. The reports indicate how a subject's balance score may have changed between testing sessions, and whether the measured change is likely due to measurement error and normal human variation in performance of the selected balance stance or a real change in performance caused by an external factor. Using proprietary software on an Android tablet and the Edge Sensor, the ClearEdge Balance System tests balance by administering eight select balance stances.
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