510(k) K021755

APEX MEDICAL DIGITAL TENS TS1211, TS1212 by Apex Medical Corp. — Product Code GZJ

K021755 is an FDA 510(k) premarket notification submitted by Apex Medical Corp. for the device "APEX MEDICAL DIGITAL TENS TS1211, TS1212". The FDA issued a decision of Substantially Equivalent on Jun 12, 2002. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Apex Medical Corp. has 35 other 510(k) clearances on record.