Cleared Traditional

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

K243775 · Excite Medical of Tampa Bay, LLC · Physical Medicine

Jul 2025

Decision

221d

Days

Class 2

Risk

About This 510(k) Submission

K243775 is an FDA 510(k) clearance for the True Non-Surgical Spinal Decompression System (DRX9000-SL), a Equipment, Traction, Powered (Class II — Special Controls, product code ITH), submitted by Excite Medical of Tampa Bay, LLC (Tampa, US). The FDA issued a Cleared decision on July 18, 2025, 221 days after receiving the submission on December 9, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K243775 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2024
Decision Date	July 18, 2025
Days to Decision	221 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF