
Alleva Medical Devices
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extriCARE® 1000 Negative Pressure Wound Therapy System is an FDA 510(k)-cleared medical device (K251646) manufactured by Alleva Medical Devices. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 2025. Regulation: 8.