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510(k) Data Aggregation

    K Number
    K121590
    Device Name
    VESTIBULAR ANALYSIS APPARATUS
    Manufacturer
    CAPACITY SPORTS, LLC
    Date Cleared
    2012-09-20

    (112 days)

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

    CAPACITY SPORTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sway™ 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 individual 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. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.
    Device Description
    The Sway Balance™ System is a mobile measurement system that analyzes balance through thoracic sway, using the built in accelerometer of a mobile device. The Sway Balance™ System is a stand-alone mobile operating system software application that does not include any peripheral hardware add-ons.
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