510(k) K210202

BioWaveGO RX by Biowave Corporation — Product Code GZJ

K210202 is an FDA 510(k) premarket notification submitted by Biowave Corporation for the device "BioWaveGO RX". The FDA issued a decision of Substantially Equivalent on February 24, 2021. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Biowave Corporation has at least 7 other 510(k) clearances on record.