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510(k) Data Aggregation

    K Number
    K150494
    Device Name
    Proteus Digital Health Feedback Device
    Manufacturer
    PROTEUS DIGITAL HEALTH, INC.
    Date Cleared
    2015-06-27

    (122 days)

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

    PROTEUS DIGITAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proteus® Digital Health Feedback Device consists of a miniaturized, wearable sensor for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), and time-stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. When the ingestible sensor is ingested, the Proteus Digital Health Feedback Device is intended to log, track and trend intake times. When co-ingested with medication, the tracking and trending of intake times may be used as an aid to measure medication adherence. The Proteus Digital Health Feedback Device may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable, and enables unattended data collection for clinical and research applications.
    Device Description
    The Proteus Digital Health Feedback Device consists of a wearable sensor, an ingestible sensor, and a software application. The Proteus wearable sensor is a body-worn sensor that collects physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity (body position), skin temperature, and time-stamped user-logged events signaled by the co-incidence with, or coingestion with, the Proteus ingestible sensor. The display application of the Proteus Digital Health Feedback Device may be used to analyze circadian rhythms and patterns. The ingestible sensor is embedded inside an inactive tablet. (the Proteus Pill or sensorenabled pill) for ease of handling and swallowing. After the ingestible sensor reaches the stomach, it activates and communicates its presence with a unique identifier to the wearable sensor. When the ingestible sensor is co-ingested with medication, the Proteus device is intended to log, track, and trend medicine intake times as an aid to measure medication adherence. The software application receives the data from the wearable sensor for further processing and analysis of the physiological and behavioral metrics. The processed data is then sent to the user interface (UI) for display as well as to Proteus databases for storage and sharing.
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    K Number
    K133263
    Device Name
    PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)
    Manufacturer
    PROTEUS DIGITAL HEALTH, INC.
    Date Cleared
    2014-02-07

    (107 days)

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

    PROTEUS DIGITAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proteus Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.
    Device Description
    The Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics such as heart tate, activity, body angle relative to gravity, and time-stamped user-logged events generated by swallowing the Proteus Ingestible Sensor. The Ingestible Sensor is embedded inside an inactive tablet (the Pill) for ease of handling and swallowing. Once the Ingestible Sensor reaches the stomach, it activates and communicates its presence and unique identifier to the Patch stores and wirelessly sends the physiological, behavioral, event, and ingestion data to a general computing device for display.
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    K Number
    K131524
    Device Name
    PROTEUS PATCH INCLUDING INGESTIBLE SENSOR
    Manufacturer
    PROTEUS DIGITAL HEALTH, INC.
    Date Cleared
    2013-06-23

    (26 days)

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

    PROTEUS DIGITAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proteus® Patch is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral metrics is desirable.
    Device Description
    The Proteus Patch is a body-worn sensor that collects physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped user-logged events generated by swallowing the Proteus Ingestible Sensor. The Ingestible Sensor is embedded inside an inactive tablet (the Pill) for ease of handling and swallowing. Once the Ingestible Sensor reaches the stomach, it activates and communicates its presence and unique identifier to the Patch. The Patch stores and wirelessly sends the physiological, behavioral, event, and ingestion data to a general computing device for display.
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    K Number
    K131009
    Device Name
    PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
    Manufacturer
    PROTEUS DIGITAL HEALTH, INC.
    Date Cleared
    2013-05-07

    (26 days)

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

    PROTEUS DIGITAL HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Proteus® Patch, also called the Patch, is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral heart rate, activity, and body position is desirable.
    Device Description
    Like the Proteus Personal Monitor (K113070), the Proteus 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 by swallowing the Proteus Ingestible Sensor. The Ingestible Sensor is embedded inside an inactive tablet (the Pill) for ease of handling and swallowing. Once the Ingestible Sensor reaches the stomach, it activates and communicates its presence and unique identifier to the Patch. The Patch stores and wirelessly sends the physiologic, event, accelerometry, and Ingestible Sensor data to a general computing device for display.
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