510(k) K031116

VECTRA (INTELECT) EPR ULTRASOUND by Chattanooga Group — Product Code IMI

K031116 is an FDA 510(k) premarket notification submitted by Chattanooga Group for the device "VECTRA (INTELECT) EPR ULTRASOUND". The FDA issued a decision of Substantially Equivalent on December 3, 2003. 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. Chattanooga Group has at least 10 other 510(k) clearances on record.