
Electro Kinetic Technologies, LLC
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BREEZE ELECTRIC TRANSPORT CHAIR MODEL 1025 is an FDA 510(k)-cleared medical device (K111095) manufactured by Electro Kinetic Technologies, LLC. 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 August 2, 2011. Regulation: 8.