Barrier EasyWarm Active Self-Warming Blanket

K232508 is the FDA 510(k) clearance record for Barrier EasyWarm Active Self-Warming Blanket, a class II device, cleared for Molnlycke Health Care Us, LLC on 2023-09-15 under FDA product code DWJ (System, Thermal Regulating). FDA's definition for product code DWJ reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 27 510(k) clearances for Molnlycke Health Care Us, LLC, from 2006-12-20 to 2023-09-15. As of 2026-09-10, FDA records show no recalls naming K232508.