510(k) K190285

L300 Go System by Bioness, Inc. — Product Code GZI

K190285 is an FDA 510(k) premarket notification submitted by Bioness, Inc. for the device "L300 Go System". The FDA issued a decision of Substantially Equivalent on March 14, 2019. 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.