VAX-D GENESIS G2 SYSTEM

VAX-D GENESIS G2 SYSTEM is an FDA 510(k)-cleared medical device (K071347) manufactured by Vax-D Medical Technologies, 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 October 4, 2007. Regulation: 8.