Perin Health System (PHD80060-2)

Perin Health System (PHD80060-2) is an FDA 510(k)-cleared medical device (K252984) manufactured by Perin Health Devices, 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 January 21, 2026. Regulation: 8.