510(k) K092448

HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 by Hivox Biotek, Inc. — Product Code GZJ

K092448 is an FDA 510(k) premarket notification submitted by Hivox Biotek, Inc. for the device "HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2". The FDA issued a decision of Substantially Equivalent on March 30, 2010. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Hivox Biotek, Inc. has at least 10 other 510(k) clearances on record.