510(k) K111279

NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM by Zynex Medical, Inc. — Product Code IPF

K111279 is an FDA 510(k) premarket notification submitted by Zynex Medical, Inc. for the device "NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 2011. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Zynex Medical, Inc. has at least 4 other 510(k) clearances on record.