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510(k) Data Aggregation

    K Number
    K220820
    Device Name
    Parky App
    Manufacturer
    H2O Bilisim Yazilim
    Date Cleared
    2022-11-17

    (241 days)

    Product Code
    GYD, ISD, NXQ
    Regulation Number
    882.1950
    Why did this record match?
    Applicant Name (Manufacturer) :

    H2O Bilisim Yazilim

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Parky App is intended to quantify kinematics of movement disorder symptoms including tremor and dyskinesia, in adults (45 years of age or older) with mild to moderate Parkinson's disease.
    Device Description
    Parky App is a symptom tracker mobile app for Parkinson's Disease patients. It collects motion data through Apple Watch continuously and quantifies tremor and dyskinesia episodes based on clinically validated MM4PD algorithm. Tracked symptoms are reported as daily, weekly and monthly. Each report is shared with the prescribing healthcare professional through email. The mobile app has a medication reminder module which the patients can manually enter their medication schedule, receive on-time reminder notifications on Apple Watch and iPhone and can respond to them as "taken" or "not yet taken". Parky also reports daily step counts provided by Apple Services - HealthKit.
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