510(k) K021952

HIVOX DREAMATE DM-800 by Hivox Biotek, Inc. — Product Code GZJ

K021952 is an FDA 510(k) premarket notification submitted by Hivox Biotek, Inc. for the device "HIVOX DREAMATE DM-800". The FDA issued a decision of Substantially Equivalent on May 2, 2003. 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.