ISOSTATION ANKLE/SUBTALAR MACHINE A-100

ISOSTATION ANKLE/SUBTALAR MACHINE A-100 is an FDA 510(k)-cleared medical device (K844060) manufactured by Isotechnologies, 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 22, 1984. Regulation: 8.