510(k) K062641

BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 by Avazzia, Inc. — Product Code GZJ

K062641 is an FDA 510(k) premarket notification submitted by Avazzia, Inc. for the device "BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1". The FDA issued a decision of Substantially Equivalent on Apr 30, 2007. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Avazzia, Inc. has 3 other 510(k) clearances on record.