
Encision, Inc.
Free shipping on orders over $99 · 30-day returns
AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 is an FDA 510(k)-cleared medical device (K093622) manufactured by Encision, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 19, 2010. Regulation: 8.