510(k) K122784

NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT by Bioness, Inc. — Product Code GZI

K122784 is an FDA 510(k) premarket notification submitted by Bioness, Inc. for the device "NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT". The FDA issued a decision of Substantially Equivalent on December 27, 2012. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Bioness, Inc. has at least 10 other 510(k) clearances on record.