POLYTEL(R) APT MODEL: PWA-08-01

POLYTEL(R) APT MODEL: PWA-08-01 is an FDA 510(k)-cleared medical device (K100524) manufactured by Polymap Wireless, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2010. Regulation: 8.