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510(k) Data Aggregation

    K Number
    K173669
    Device Name
    K-D Balance
    Manufacturer
    King-Devick Technologies, Inc.
    Date Cleared
    2018-04-02

    (123 days)

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

    King-Devick Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K-D Balance is an objective balance assessment tool and is intended to be used for individuals for whom a balance measurement is a desired outcome. K-D Balance is intended for use to assess balance performance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified or licensed in their state to prescribe and use balance devices including but not limited to athletic trainers and coaches, physical therapists, nurses, physicians, and other health care providers. Patients with could affect balance include, but are not limited to, vestibular dysfunction, nausea, headaches, orthopedic injury, inner ear infection or dysfunction, neurological conditions, head injury, medication side effects, dehydration and fatigue. K-D Balance can be used wherever an iOS mobile operating device is available. K-D Balance may only be used by health care professionals.
    Device Description
    K-D Balance is a mobile balance test to be used on the 6th generation iPhone or iPod touch with iOS versions 9.0 or later. K-D Balance measures balance using motion sensors already built-in to the iPhone or iPod touch devices. K-D Balance utilizes a proprietary 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 secured to the subject with a device holder. Health care professionals 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. K-D Balance does not function as a diagnostic test, and K-D Balance results should be interpreted by healthcare professionals only.
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