510(k) K010209

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

K010209 is an FDA 510(k) premarket notification submitted by Biomedical Life Systems, Inc. for the device "ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL". The FDA issued a decision of Substantially Equivalent on June 12, 2001. 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.