True Non-Surgical Spinal Decompression System (DRX9000-SL)

True Non-Surgical Spinal Decompression System (DRX9000-SL) is an FDA 510(k)-cleared medical device (K243775) manufactured by Excite Medical of Tampa Bay, 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 July 17, 2025. Regulation: 8.