Hi-Dow Wireless TENS/EMS System (Model HD-5N)

Hi-Dow Wireless TENS/EMS System (Model HD-5N) is an FDA 510(k)-cleared medical device (K163393) manufactured by Hi-Dow International, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 3, 2017. Regulation: 8.