ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)

ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) is an FDA 510(k)-cleared medical device (K152852) manufactured by Bayer Healthcare, LLC. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2015. Regulation: 8.