LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM

LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM is an FDA 510(k)-cleared medical device (K132016) manufactured by Texas Applied Biomedical Services, 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 June 1, 2014. Regulation: 8.