QUADRA BLOC TENS, MODEL 101

QUADRA BLOC TENS, MODEL 101 is an FDA 510(k)-cleared medical device (K062547) manufactured by Gradient Technologies, 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 20, 2007. Regulation: 8.