SPRY TMS Therapy System (0550)

SPRY TMS Therapy System (0550) is an FDA 510(k)-cleared medical device (K251653) manufactured by Soterix Medical, 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 19, 2026. Regulation: 8.