510(k) K152437

BiowaveHOME Neuromodulation Pain Therapy Device by Biowave Corporation — Product Code GZJ

K152437 is an FDA 510(k) premarket notification submitted by Biowave Corporation for the device "BiowaveHOME Neuromodulation Pain Therapy Device". The FDA issued a decision of Substantially Equivalent on September 25, 2015. 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.