INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE

INNOVA RECTAL OR SMALL VAGINAL EMG SENSING ELECTRODE is an FDA 510(k)-cleared medical device (K952688) manufactured by Empi. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 1995. Regulation: 8.