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U.S. Department of Health and Human Services

Product Classification
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Device uterine electromyographic monitor
Regulation Description External uterine contraction monitor and accessories.
Definition The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.
Physical State Monitor with associated electronics and patient skin electrodes.
Technical Method abdominal EMG surface electrodes that pick up electrical activity from the uterus in labor, electrical signal converted to a monitor tracing.
Target Area Maternal abdomen and uterus
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeOSP
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.2720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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