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510(k) Data Aggregation

    K Number
    K243566
    Device Name
    CardioTag™
    Manufacturer
    Cardiosense, Inc.
    Date Cleared
    2025-07-22

    (246 days)

    Product Code
    DXR, DPS, DRG, JOM
    Regulation Number
    870.2320
    Why did this record match?
    Product Code :

    DXR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CardioTag device is a tool that can be used to record, display and transfer vibrational waveforms produced by the heart contractions and transmitted to the chest as well as single-channel electrocardiogram (ECG) rhythms and heart rate. It also measures pulse waveform and pulse rate by photoplethysmograph (PPG). The CardioTag may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle. The CardioTag is intended for spot-checking of adult patients in clinics or at home under the care of a physician. The data from the CardioTag is intended for use by healthcare professionals as an aid to diagnosis and treatment.
    Device Description
    The CardioTag device consists of a rechargeable wearable that is responsible for collecting raw cardiac signals from a single patient, and produces a spot-check report of a patient's electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals and heart rate. To generate the report, the user places the wearable on the sternum and starts a 2 minute recording session for waveform output and heart rate /pulse rate calculation. The wearable contains electrodes to measure single-lead ECG, light sources and optical sensor arrays to measure PPG, and an accelerometer to measure vibrational waveforms from the heart's contractions transferred to the chest wall (SCG). Sensor data is then transferred for storage and processing to a cloud-based backend). The backend uses the recording to calculate heart rate and pulse rate and then visualizes the waveforms and heart rate in the format of a downloadable PDF report for the clinician. The SCG signal is intended to be used for manual interpretation by the clinician in conjunction with other information from the device. The device may be used as a tool to measure the timing of the aortic valve opening and closing in the cardiac cycle.
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    K Number
    K160656
    Device Name
    CorSens
    Manufacturer
    CorSens Medical Ltd.
    Date Cleared
    2016-11-21

    (258 days)

    Product Code
    DXR
    Regulation Number
    870.2320
    Why did this record match?
    Product Code :

    DXR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CorSens Device records vibrational waveforms produced by the heart contractions and transmitted to the chest wall. CorSens Device may be used as a tool to measure the timing of part of the cardiac cycle for adult population.
    Device Description
    CorSens Device senses and analyzes the mechanical movement of the heart. This is accomplished by 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motions.
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    K Number
    K081603
    Device Name
    DIGITAL BALLISTOCARDIOGRAPH, MODEL DGB 300
    Manufacturer
    HEARTFORCE MEDICAL, INC.
    Date Cleared
    2009-07-24

    (413 days)

    Product Code
    DXR, DSB, INT
    Regulation Number
    870.2320
    Why did this record match?
    Product Code :

    DXR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The dBG 300 records vibrational waveforms produced by the hearts contractions and transmitted to the chest wall. The dBG 300 may be used as a tool to measure the timing of the events in the cardiac cycle.
    Device Description
    The Heart Force Ballistocardiograph senses and analyzes the mechanical movement of the heart. This is accomplished with 2 or 3 standard ECG electrodes for the ECG signal and with a suitable miniature electronic accelerometer for the mechanical motion.
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