TENZCARE DUAL-CHANNEL STIMULATOR

TENZCARE DUAL-CHANNEL STIMULATOR is an FDA 510(k)-cleared medical device (K800758) manufactured by 3M Company. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 1980. Regulation: 8.