E.W.L. P-TENS/H-WAVE

E.W.L. P-TENS/H-WAVE is an FDA 510(k)-cleared medical device (K862121) manufactured by Electronic Waveform Laboratory, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 1987. Regulation: 8.