SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ

SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ is an FDA 510(k)-cleared medical device (K131309) manufactured by Ibramed Equipamentos Medicos. 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 January 26, 2014. Regulation: 8.