510(k) K090922

EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR by Empi — Product Code GZJ

K090922 is an FDA 510(k) premarket notification submitted by Empi for the device "EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR". The FDA issued a decision of Substantially Equivalent on June 5, 2009. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Empi has at least 10 other 510(k) clearances on record.