prolaio eVO2peak Module (Version 1.0)

prolaio eVO2peak Module (Version 1.0) is an FDA 510(k)-cleared medical device (K252204) manufactured by Prolaio, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2025. Regulation: 8.