Rune Labs Tremor Transducer System

Rune Labs Tremor Transducer System is an FDA 510(k)-cleared medical device (K213519) manufactured by Rune Labs, 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 June 9, 2022. Regulation: 8.