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Axiom Worldwide, Inc.
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DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM is an FDA 510(k)-cleared medical device (K060735) manufactured by Axiom Worldwide, 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 25, 2006. Regulation: 8.