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510(k) Data Aggregation

    K Number
    K171019
    Device Name
    ScioCardio ECG Transmitter
    Date Cleared
    2018-05-30

    (420 days)

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

    Synergen Technology Labs LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired. ScioCardio ECG transmitter acquires Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body. ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device. ScioCardio ECG transmitter transmits the acquired physiological signals in real-time to a compatible mobile phone where ScioCardio Mobile App is installed. ECG data is stored in the mobile phone verbatim without any sampling adjustment or any other modifications and also is displayed in the Mobile App. ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia. ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.
    Device Description
    ScioCardio ECG transmitter is a battery powered wearable device, capable of continuously capturing a body surface ECG from the patient, storing and transmitting the data to an external device or a system wirelessly. ECG signals are captured from the conventional solid gel electrodes worn on the body using a 3 lead ECG system. Raw ECG data is stored and transmitted wirelessly to any compatible device with Bluetooth Low Energy capability. This allows visualization, analysis and interpretation which can be used for a variety of applications such as ECG monitoring, heart rate monitoring, arrhythmia detection and analysis, out-patient monitoring etc. Other than the ECG data, ScioCardio ECG transmitter also captures, stores and transmits patient's motion data from an IMU sensor providing information about the patient's activities which can also be used in above mentioned analysis and interpretations. ScioCardio ECG transmitter is an always-on device. Data acquisition, storing and transmission are all done automatically and require no patient intervention other than initializing the device. ScioCardio ECG transmitter is small in form factor and has a higher battery life, making it possible for the user to wear the device comfortably for longer durations as per specific requirements.
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