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510(k) Data Aggregation

    K Number
    DEN120011
    Device Name
    PROTEUS INGESTION CONFINMATION SYSTEMS
    Manufacturer
    PROTEUS BIOMEDICAL, INC.
    Date Cleared
    2012-07-10

    (60 days)

    Product Code
    OZW
    Regulation Number
    880.6305
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEUS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proteus Personal Monitor is a miniaturized, wearable data-logger for ambulatory recording of heart rate, activity, body angle relative to gravity, and time-stamped, patientlogged events, including events signaled by swallowing the Ingestion Event Marker (IEM) accessory. The Proteus Personal Monitor enables unattended data collection for clinical and research applications. The Proteus Personal Monitor may be used in any instance where quantiffable analysis of event-associated heart rate, activity, and body position is desirable.
    Device Description
    The Proteus Personal Monitor, also called the "Patch", is a body-worn sensor that collects physiological and behavioral metrics including heart rate, activity, body angle and time-stamped user-logged events generated when a user marks an event by swallowing an Ingestion Event Marker (IEM) or by manually pressing an event marker button on the Patch. The Patch stores and wirelessly sends the IEM data to a general computing device. The Proteus Personal Monitor Ingestion Event Marker system is comprised of three main subsystems; (1) the ingestion event marker (IEM), (2) the data recorder (Patch), and (3) the Proteus software. 1. Ingestion Event Marker (IEM) The grain-of-sand sized IEM is designed to communicate the time-stamped confirmation of IEM device ingestion as a unique identifier to the Proteus Personal Monitor worn on the skin. The ingestion signal is communicated via volume conduction communication also known as intrabody communication. The IEM is attached to an inert pharmaceutical excipient tablet for ease of handling and swallowability. 2. Proteus Personal Monitor (Patch) The Proteus Personal Monitor (Patch) receives, stores, and wirelessly sends ingestion confirmation data to a general computing device. 3. Software The Proteus software is used to pair the Patch with a mobile computing device. The software organizes and displays ingestion events.
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    K Number
    K093976
    Device Name
    RAISIN PERSONAL MONITOR
    Manufacturer
    PROTEUS BIOMEDICAL, INC.
    Date Cleared
    2010-03-25

    (91 days)

    Product Code
    DXH
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROTEUS BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Raisin™ Personal Monitor is a miniaturized, wearable data-logger for ambulatory recording of heart rate, activity, body angle relatively to gravity, and time-stamped, patient-logged events. The Raisin™ Personal Monitor enables unattended data collection for clinical and research applications. The Raisin™ Personal Monitor may be used in any instance where quantifiable analysis of eventassociated heart rate, activity, and body position is desirable.
    Device Description
    The Raisin100 Personal Monitor (RPM) is a miniaturized, ambulatory, battery-operated datalogging device that is worn on the torso to record heart rate, activity, and patient-logged events. Patient-logged events can be extrinsic (e.g., dosing of a medication) or intrinsic (e.g., a symptom) and are time-stamped using a manual button on the device, in order to contextualize the physiologic measures. Subjective meaning of these events is assigned by the user. In addition to quantification of physical motion, signals from the device's accelerometer are used to determine body position relative to gravity. Electrode-to-electrode impedance is also measured to assess whether the device is attached properly to the user. RPM recorded data are transferred via Bluetooth telemetry to a general computing device for display and conversion for export to other programs. The RPM is available in two form factors to accommodate individual comfort preferences: one-piece and two-piece. The functionality, intended use, duration and location of wear, and fundamental scientific technologies are exactly the same between the two RPM form factors.
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