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510(k) Data Aggregation

    K Number
    K220351
    Device Name
    Polso Watch
    Date Cleared
    2022-11-18

    (284 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chronisense Medical, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Polso™ Watch is a wrist-worn device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2), pulse rate, and respiration rate. The Polso™ Watch is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor is it intended to independently guide treatment decisions. The device is not an apnea monitor. Physiological parameters will later be provided for remote review by a clinician.
    Device Description
    The Polso™ Watch is a wearable device intended for non-invasive measurements and display of pulse rate (PR), blood oxygen saturation (SpO2), and respiration rate (RR). It is a prescription-use device intended for spot-checking measurements of patients aged 18 years and older in the home use environment in non-motion conditions. The device is not intended to be used for diagnostic applications nor it is intended to independently guide treatment decisions. The Polso™ Watch is worn on the wrist and features sensors that are located facing the radial artery and at the dorsal wrist, for measurement of physiological information. The Polso™ Watch screen displays measurements, battery status, Bluetooth connection status, and time of day. The Control Button allows navigation between different display screens. The Polso™ Watch is available in sizes S, M and L to cover wrist sizes from 5.5″ to 8.4″ circumference. The Polso™ Watch is powered by a rechargeable lithium-polymer battery. The Polso™ Watch is paired with a companion mobile application (Polso™ App) on an Android device. The App is used to set up the Polso™ Watch and to review up to 3 months of measurement data.
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