
Medela AG
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INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM is an FDA 510(k)-cleared medical device (K141926) manufactured by Medela AG. 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 December 18, 2014. Regulation: 8.