510(k) K103343

L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) by Bioness, Inc. — Product Code GZI

K103343 is an FDA 510(k) premarket notification submitted by Bioness, Inc. for the device "L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)". The FDA issued a decision of Substantially Equivalent on April 29, 2011. 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.