510(k) K212618

iRelieve Microcurrent Pain Relief System by Fast Track Technologies, Inc. — Product Code GZJ

K212618 is an FDA 510(k) premarket notification submitted by Fast Track Technologies, Inc. for the device "iRelieve Microcurrent Pain Relief System". The FDA issued a decision of Substantially Equivalent on September 14, 2022. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890.