510(k) K131309

SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ by Ibramed Equipamentos Medicos — Product Code IMI

K131309 is an FDA 510(k) premarket notification submitted by Ibramed Equipamentos Medicos for the device "SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ". The FDA issued a decision of Substantially Equivalent on January 27, 2014. The device falls under product code IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5300. Ibramed Equipamentos Medicos has at least 5 other 510(k) clearances on record.