510(k) K023050

RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI by Reliant Technologies, Inc. — Product Code IMG

K023050 is an FDA 510(k) premarket notification submitted by Reliant Technologies, Inc. for the device "RELIANT BTL 5000 PULS ELECTRICAL STIMULATION SYSTEM, RELIANT BTL 5000 SONO ULTRASOUND SYSTEM, RELIANT BTL 5000 COMBI". The FDA issued a decision of Substantially Equivalent on February 14, 2003. 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. Reliant Technologies, Inc. has at least 10 other 510(k) clearances on record.