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510(k) Data Aggregation

    K Number
    K191620
    Device Name
    Vitls Platform
    Manufacturer
    Vitls Inc.
    Date Cleared
    2020-06-01

    (349 days)

    Product Code
    DRG, FLL
    Regulation Number
    870.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vitls Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitls Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in in healthcare and home settings. This includes heart rate (HR) and body tomperature. The data from the Tego VSS Sensor is intended for use by healthcare professionals as an aid to diagnosis and treatment. It is not intended for use on critical care patients nor replace standard monitoring and/or rouance care, The device is intended for use as a general patient monitor, to provide physiological information, on patients who are 2 years of age or older.
    Device Description
    The Vitls Platform is a wireless multi-parameter vital signs monitoring system. The Vitls Platform was developed to include an Application Programming Interface (API) which is intended to allow development of user interface applications, enabling clinicians and medically qualified personnel to access recorded vital signs information for respective analysis only, not for active patient monitoring. The Vitls Platform consists of: Wearable device with multiple sensors (the Tego VSS Sensor – An Adhesive Patch with integrated Sensors) The Secure Server Library (Cloud-based, including an API) The Vitls App (accessible on a smartphone, tablet, PC or monitor that displays the data and configures the Tego VSS Sensor) The Tego VSS Sensor is a battery-operated adhesive patch with integrated sensors and wireless transceiver which is worn on the upper body and records heart rate and body temperature. There are two different sizes, one for adult and one for pediatric patients, they are 140 cm and 80 cm in length of the flexible portion of the sensor, respectively. The Tego VSS Sensor continuously gathers multiparameter vital signs data from the person being monitored and then transmits the encrypted data via bi-directional communication to the third-party connectivity relay, when in range. When not in range, the collected data is stored on the Tego VSS Sensor (for a maximum of 3 hours) and transmitted when a connection with the third-party connectivity relay has been restored. The encrypted wireless data recorded by the Sensor is sent, by the third-party connectivity relay, to the Secure Server. The data may be downloaded from the Secure Server Library or integrated into a Third-Party Application via the APIs of the Secure Server Library. In addition, the wireless data may be transferred to an optional Secure Server Library where they may be stored for future analysis.
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