510(k) K090542

SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 by Sun-Rain System Corp. — Product Code IMI

K090542 is an FDA 510(k) premarket notification submitted by Sun-Rain System Corp. for the device "SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900". The FDA issued a decision of Substantially Equivalent on October 23, 2009. 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.