510(k) K024013

SUN-RAIN ULTRASONIC THERAPY, SU-100 by Sun-Rain System Corp. — Product Code IMI

K024013 is an FDA 510(k) premarket notification submitted by Sun-Rain System Corp. for the device "SUN-RAIN ULTRASONIC THERAPY, SU-100". The FDA issued a decision of Substantially Equivalent on October 31, 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. Sun-Rain System Corp. has at least 2 other 510(k) clearances on record.