SONOPULSE/ SONOPULSE III

SONOPULSE/ SONOPULSE III is an FDA 510(k)-cleared medical device (K130888) manufactured by Ibramed- Industria Brazileria DE Equipamentos Medi. 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 8, 2014. Regulation: 8.