SMALL VAGINAL/RECTAL ELECTRODE

SMALL VAGINAL/RECTAL ELECTRODE is an FDA 510(k)-cleared medical device (K983206) manufactured by Empi. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 2, 1998. Regulation: 8.