510(k) K052813

FD TENS 2030, MODEL DFJ24T by Fuji Dynamics Limited — Product Code GZJ

K052813 is an FDA 510(k) premarket notification submitted by Fuji Dynamics Limited for the device "FD TENS 2030, MODEL DFJ24T". The FDA issued a decision of Substantially Equivalent on January 25, 2006. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Fuji Dynamics Limited has at least 6 other 510(k) clearances on record.