Cleared Traditional

DRX9000C-SL Cervical Spinal Decompression System

K243366 · Excite Medical of Tampa Bay, LLC · Physical Medicine

Jun 2025

Decision

233d

Days

Class 2

Risk

About This 510(k) Submission

K243366 is an FDA 510(k) clearance for the DRX9000C-SL Cervical Spinal Decompression System, 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 June 18, 2025, 233 days after receiving the submission on October 28, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number	K243366 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2024
Decision Date	June 18, 2025
Days to Decision	233 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF