ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)

ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) is an FDA 510(k)-cleared medical device (K171802) 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 March 6, 2018. Regulation: 8.