510(k) K031374

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 by Besmed Health Business Corp — Product Code GZJ

K031374 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "BESMED VARIOUS MODELS OF TENS, BE-550/BE-660". The FDA issued a decision of Substantially Equivalent on November 28, 2003. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.