Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac

Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac is an FDA 510(k)-cleared medical device (K214037) manufactured by Ergo-Flex Technologies, LLC. 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 February 21, 2024. Regulation: 8.