510(k) K261522

BioWave BioWraps by Biowave Corporation — Product Code GXY

K261522 is an FDA 510(k) premarket notification submitted by Biowave Corporation for the device "BioWave BioWraps". The FDA issued a decision of Substantially Equivalent on June 3, 2026. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Biowave Corporation has at least 7 other 510(k) clearances on record.