
Etac Sverige AB
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BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) is an FDA 510(k)-cleared medical device (K072475) manufactured by Etac Sverige AB. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2007. Regulation: 8.