510(k) K243775

True Non-Surgical Spinal Decompression System (DRX9000-SL) by Excite Medical of Tampa Bay, LLC — Product Code ITH

K243775 is an FDA 510(k) premarket notification submitted by Excite Medical of Tampa Bay, LLC for the device "True Non-Surgical Spinal Decompression System (DRX9000-SL)". The FDA issued a decision of Substantially Equivalent on July 18, 2025. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900. Excite Medical of Tampa Bay, LLC has at least 1 other 510(k) clearance on record.