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U.S. Department of Health and Human Services

Product Classification

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Device ingestible event marker
Regulation Description Ingestible event marker.
Definition To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device
Physical State The system is composed of an ingestible microsensor, a data recorder in the form of a skin patch, and software
Technical Method The grain-of-sand sized microsensor is designed to communicate the time-stamped confirmation of dosing as a unique identifier to the Proteus ingestion recorder worn on the skin. The ingestion signal is communicated via volume conduction communication also known as intra-body communication. The IEM is attached to an inert pharmaceutical excipient tablet for ease of handling and swallowability.
Target Area Digestive tract.
Regulation Medical Specialty General Hospital
Review Panel Cardiovascular
Product CodeOZW
Premarket Review Office of Cardiovascular Devices (OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type 510(k)
Regulation Number 880.6305
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible