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U.S. Department of Health and Human Services

Product Classification
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Device gastrointestinal motility system, capsule
Regulation Description Gastrointestinal motility monitoring system.
Definition Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Physical State Small ingestible capsule transmits motility data to a wireless receiver worn by the subject. Data from the receiver is dowloaded into a personal computer (PC) and analyzed with custom software.
Technical Method Ingestible telemetric capsule that transmits GI motility data to a wireless receiver worn by the patient.
Target Area Device is swallowed, and passes through the GI tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodeNYV
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.1725
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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