STARband, STARlight, St. Louis Band

STARband, STARlight, St. Louis Band is an FDA 510(k)-cleared medical device (K180109) manufactured by Orthomerica Products, 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 February 28, 2018. Regulation: 8.