510(k) K813601

E.W.L. P-TENS MODEL(TENS by Electronic Waveform Laboratory, Inc. — Product Code GZJ

K813601 is an FDA 510(k) premarket notification submitted by Electronic Waveform Laboratory, Inc. for the device "E.W.L. P-TENS MODEL(TENS". The FDA issued a decision of Substantially Equivalent on March 19, 1982. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Electronic Waveform Laboratory, Inc. has at least 5 other 510(k) clearances on record.