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Invacare Corp.
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INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 is an FDA 510(k)-cleared medical device (K020386) manufactured by Invacare Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 1, 2002. Regulation: 8.