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510(k) Data Aggregation

    K Number
    K180487
    Device Name
    Peak.me
    Manufacturer
    Breathe me LTD
    Date Cleared
    2018-10-26

    (245 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Breathe me LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peak.me is intended for monitoring FEVI (Forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for adult users and pediatric children over 5 years of age with caregiver supervision. Peak.me is not recommended for children under 5 years of age.
    Device Description
    Peak.me is a hand-held Peak Flow Meter device that is intended for monitoring FEV1 (forced exhalation in the first second) and PEF (peak expiratory flow) for home use. The device is designed for pediatric to adult users. Peak.me is not recommended for children under 5 years of age. Peak.me consists of a mechanical unit, which physically attaches to the user's smartphone, and a software application which analyzes the measurements and serves as a disease management platform. The device uses the smartphone's internal upper microphone as a sensor and does not include any electrical parts. As the user exhales through the mechanical unit, it produces acoustic waves with a frequency proportional to the exhalation airflow rate, which then propagates to the smartphone's internal upper microphone. Peak.me software application analyzes the sound and displays the results. Furthermore, the application includes a review of past measurements. It enables manual input of symptoms and medication usage and provides guidance for correct usage and more.
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