510(k) K033455

ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5 by Biomedical Life Systems, Inc. — Product Code GZJ

K033455 is an FDA 510(k) premarket notification submitted by Biomedical Life Systems, Inc. for the device "ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5". The FDA issued a decision of Substantially Equivalent on January 15, 2004. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Biomedical Life Systems, Inc. has at least 10 other 510(k) clearances on record.