510(k) K153456

Megapulse III Shortwave Diathermy by Accelerated Care Plus — Product Code IMJ

K153456 is an FDA 510(k) premarket notification submitted by Accelerated Care Plus for the device "Megapulse III Shortwave Diathermy". The FDA issued a decision of Substantially Equivalent on June 14, 2016. The device falls under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Accelerated Care Plus has at least 2 other 510(k) clearances on record.