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U.S. Department of Health and Human Services

Product Classification

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Device gastrointestinal motility system, capsule
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
Review Panel Gastroenterology/Urology
Product CodeNYV
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible