True Non-Surgical Spinal Decompression System (DRX9000-SL)— 510(k) K243775

Name: FDA 510(k) clearance K243775
Creator: U.S. Food and Drug Administration
Published: 2025-07-18

Substantially Equivalent

Excite Medical of Tampa Bay, LLC

FDA 510(k) clearance K243775 for True Non-Surgical Spinal Decompression System (DRX9000-SL), Substantially Equivalent on 2025-07-18. Applicant: Excite Medical of Tampa Bay, LLC. Device class: 2.

Clearance details

Applicant: Excite Medical of Tampa Bay, LLC
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2024-12-09
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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