Nimbl (model PD08-N1)

Nimbl (model PD08-N1) is an FDA 510(k)-cleared medical device (K234155) manufactured by Tactile Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 2024. Regulation: 8.