NeurotriS (SX2500); NeurotriS (SX3800)

NeurotriS (SX2500); NeurotriS (SX3800) is an FDA 510(k)-cleared medical device (K251909) manufactured by A-1 Engineering. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 2025. Regulation: 8.