510(k) K861864

MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT by I-Rep, Inc. — Product Code IMJ

K861864 is an FDA 510(k) premarket notification submitted by I-Rep, Inc. for the device "MEDTRON TYPE P-300 ULTRASONIC THERAPY UNIT". The FDA issued a decision of Substantially Equivalent on July 14, 1986. 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. I-Rep, Inc. has at least 7 other 510(k) clearances on record.