K243775 is an FDA 510(k) clearance for the True Non-Surgical Spinal Decompression System (DRX9000-SL). This device is classified as 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 FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K243775 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | ITH - Equipment, Traction, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5900 |