SETMA FHT, MODEL ST 8130

SETMA FHT, MODEL ST 8130 is an FDA 510(k)-cleared medical device (K854263) manufactured by Setma, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1985. Regulation: 8.