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510(k) Data Aggregation

    K Number
    K180479
    Device Name
    ReDS System
    Manufacturer
    Sensible Medical Innovations Ltd.
    Date Cleared
    2019-02-28

    (371 days)

    Product Code
    DSB
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sensible Medical Innovations Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReDS System is intended for use by qualified healthcare practitioners, under the direction of a physician, in hospitals, hospital-type facilities and home environments, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. The ReDS System is indicated for patients: - With fluid management problems - Taking diuretic medication - Living with heart failure - Recovering from a coronary artery disease-related event
    Device Description
    The ReDS System ("ReDS" or "ReDS System") is a non-invasive thoracic base wave impedance monitor that provides measurement of patient lung fluid content. ReDS™ technology measures wave impedance of biological tissues. Low power electromagnetic (EM) signals are emitted into the body, and intercepted by sensors on the body. The wave impedance is a function of the distributed tissue conductivity and capacitance properties, and is representative of tissue fluid content. The system consists of a Sensor Unit connected to a bedside console, as well as a cloud application. The Sensor Unit encases two sensors and an attachment mechanism. The Bedside Console is an enclosure housing the electronic modules, an embedded computer and a touch-screen display. The device software provides the management of the device as well as analysis of the measured signals, graphic display of readings, reporting, and communications functionality to enable remote patient monitoring.
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    K Number
    K150095
    Device Name
    ReDs Wearable System
    Manufacturer
    SENSIBLE MEDICAL INNOVATIONS LTD.
    Date Cleared
    2015-08-06

    (202 days)

    Product Code
    DSB
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    SENSIBLE MEDICAL INNOVATIONS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ReDS is intended for use by qualified health care practitioners and by patients, under the direction of a physician, in hospitals, hospital-type facilities and home environment, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications. ReDS is indicated for patients: - With fluid management problems - Taking diuretic medication - Living with Heart Failure - Recovering from Coronary Artery Disease related event .
    Device Description
    The ReDS Wearable System ("ReDS") is a non-invasive thoracic base wave impedance monitor that provides measurement of patient lung fluid content. ReDS™ technology measures wave impedance of biological tissues. Low power electromagnetic (EM) signals are emitted into the body, and intercepted by sensors on the body. The wave impedance is a function of the distributed tissue conductivity and capacitance properties, and is representative of tissue fluid content. The system consists of a Wearable Vest connected to a bedside console, as well as a cloud application. The Wearable Vest encases two sensors and an attachment mechanism. The Bedside Console is an enclosure housing the electronic modules, an embedded computer and a touch-screen display. The device software provides the management of the device as well as analysis of the measured signals, graphic display of readings, reporting, and communications functionality to enable remote patient monitoring.
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