MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM

MEDICAL DESIGNS, INC. BIO-THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K911911) manufactured by Medical Design & Manufacturing Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 1992. Regulation: 8.