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510(k) Data Aggregation

    K Number
    K183052
    Device Name
    ID-Cap System
    Manufacturer
    etectRx, Inc.
    Date Cleared
    2019-12-06

    (399 days)

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

    etectRx, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.
    Device Description
    The ID-Cap System is an ingestible event marker. It utilizes an in vivo communications technology that emits a very low power radio frequency (RF) digital message from within the patient after a sensor is ingested and detects the signal using a wearable Reader. The ID-Cap System is comprised of the ID-Capsule, the ID-Cap Reader, and related software which allows data to be displayed for the patient and clinician. The ID-Capsule consists of a standard pharmaceutical capsule shell containing the ID-Tag (the ingestible sensor). The ID-Cap Reader is a wearable device, which receives the message from the ID-Tag, verifies the message as being a valid ingestion event, and forwards the data using the Bluetooth Low Energy (BLE) protocol to data display systems utilized by clinicians and patients.
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