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510(k) Data Aggregation

    K Number
    K221772
    Device Name
    NeuroRPM
    Manufacturer
    New Touch Digital Inc.
    Date Cleared
    2023-03-17

    (269 days)

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

    New Touch Digital Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NeuroRPM is intended to quantify movement disorder symptoms during wake periods in adult patients 46 to 85 years of age with Parkinson's disease. These symptoms include tremor, bradykinesia, and dyskinesia. NeuroRPM is intended for clinic and home environments.
    Device Description
    NeuroRPM is a software application for the Apple Watch that is prescribed by a health professional to quantify motor symptoms of Parkinson's disease including bradykinesia, dyskinesia, and tremor. NeuroRPM collects accelerometer and gyroscope data from the Apple Watch. The motion data are transmitted to cloud servers and analyzed using machine learning models developed to generate binary symptom classifications. Binary symptom classification output is generated every 15-minutes.
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