510(k) K052340

DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM by Alfa Tech Medical Systems, Ltd. — Product Code IMG

K052340 is an FDA 510(k) premarket notification submitted by Alfa Tech Medical Systems, Ltd. for the device "DU857 DUAL FREQUENCY ULTRASOUND THERAPY AND MUSCLE STIMULATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 9, 2005. The device falls under product code IMG (Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5860. Alfa Tech Medical Systems, Ltd. has at least 1 other 510(k) clearance on record.