
Conmed Linvatec
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ZEN WIRELESS FOOTSWITCH (W1000), ZEN WIRELESS FOOTSWITCH ADAPTER (W1100) is an FDA 510(k)-cleared medical device (K083161) manufactured by Conmed Linvatec. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 26, 2009. Regulation: 8.