510(k) K131720

HIVOX SELF ADHESIVE ELECTRODE GEL PADS by Hivox Biotek, Inc. — Product Code GXY

K131720 is an FDA 510(k) premarket notification submitted by Hivox Biotek, Inc. for the device "HIVOX SELF ADHESIVE ELECTRODE GEL PADS". The FDA issued a decision of Substantially Equivalent on July 25, 2014. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Hivox Biotek, Inc. has at least 10 other 510(k) clearances on record.