TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3

TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3 is an FDA 510(k)-cleared medical device (K912015) manufactured by Empi. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 1991. Regulation: 8.