510(k) K061650

SELECT TENS, MODEL 4600S by Empi — Product Code GZJ

K061650 is an FDA 510(k) premarket notification submitted by Empi for the device "SELECT TENS, MODEL 4600S". The FDA issued a decision of Substantially Equivalent on January 22, 2007. 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.