SimpleSense-BP, SimpleSense-BP Software Application

SimpleSense-BP, SimpleSense-BP Software Application is an FDA 510(k)-cleared medical device (K232053) manufactured by Nanowear, 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 7, 2023. Regulation: 8.