FitRelief TENS&EMS Wireless Device

FitRelief TENS&EMS Wireless Device is an FDA 510(k)-cleared medical device (K191938) manufactured by Heat IN A Click, LLC. 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 August 27, 2020. Regulation: 8.