510(k) K121059

SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM by Zimmer Medizinsystems GmbH — Product Code IMG

K121059 is an FDA 510(k) premarket notification submitted by Zimmer Medizinsystems GmbH for the device "SOLEOLINE, SOLEO STIM, SOLEO SONO, SOLEO SONOSTIM". The FDA issued a decision of Substantially Equivalent on August 7, 2012. 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. Zimmer Medizinsystems GmbH has at least 1 other 510(k) clearance on record.