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510(k) Data Aggregation

    K Number
    K191870
    Device Name
    VV330 Continuous ECG Platform, VivaLNK Adhesive Patch
    Manufacturer
    Date Cleared
    2020-01-07

    (179 days)

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

    VivaLNK, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.
    Device Description
    The VV330 Continuous ECG Platform is a single-channel, rechargeable, re-usable, ambulatory medical-grade continuous ECG recorder, intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording systems intended for use on general care patients and on patients who are 18 years of age or older. The VV330 Continuous ECG Platform is an ECG acquisition, storage, and transmission devices that utilizes disposable adhesive to maintain contact with the patient's skin and a hydrogel to promote electrical connectivity. The Platform has a re-usable sensor/recorder module allowing collection, storage and transfer of physiological data such as electrocardiogram (ECG), Accelerometer data, R-R Interval (RRI) and Heart Rate (HR). The Platform has a mobile data-display application built from a proprietary Software Library. And it also allows Authorized Persons to build their own applications using the same Software Library. User's physiological are not transferred to healthcare professionals directly in any way; healthcare professionals can only view the data on the intended device (such as a mobile phone). User may view the physiological data in real time from the smart phone (or similar devices) while it records the data. The Subject device provides operational alarms such as lead on/off status detection, battery monitoring, Over the Air (OTA) updates, real time clock, and power management. The operational alarms are intended to notify users of any interruption in data and of the overall operation status of the Recorder. The Subject device, being just a Transmitters and Receivers of Physiological Signal, does not provide any alarms based on physiological data setting.
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