EMS100 Tri-Wave Combination Stimulator

EMS100 Tri-Wave Combination Stimulator is an FDA 510(k)-cleared medical device (K171387) manufactured by Elite Medical Supply of New York, LLC. 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 May 30, 2017. Regulation: 8.