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E1 Ent., Inc.
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CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR is an FDA 510(k)-cleared medical device (K080385) manufactured by E1 Ent., Inc.. 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 May 12, 2008. Regulation: 8.