510(k) K031329

DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) by Dynatronics Corp. — Product Code IMI

K031329 is an FDA 510(k) premarket notification submitted by Dynatronics Corp. for the device "DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)". The FDA issued a decision of Substantially Equivalent on October 22, 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. Dynatronics Corp. has at least 10 other 510(k) clearances on record.