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510(k) Data Aggregation

    K Number
    K223163
    Device Name
    Sleepiz One+
    Manufacturer
    Sleepiz AG
    Date Cleared
    2023-08-18

    (315 days)

    Product Code
    DRT, BZQ
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sleepiz AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition). The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ web application is Intended for use by healthcare professionals. Sleepiz One+ device can also detect the presence of patients and their body movements at rest or during sleep. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women or patients with active implantable devices.
    Device Description
    Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate. The device is placed on a bedside table or a stand, mounted slightly higher than the mattress level, from where it detects the presence of a patient and their physiological signals. From that position, distance changes between the device and the patient's body are captured by Doppler radar. The recorded signals are then transmitted to the cloud software where these are analyzed by the signal processing software ("Sleep Analytics Software") to obtain respiration rate, heart rate and facilitate the monitoring of the presence of the patient and their body movement. These outputs are then displayed on the web application to allow the annotation of the data, compilation of results into reports, and the management of the hardware units.
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