DRX9000C-SL Cervical Spinal Decompression System
FDA 510(k) K243366 · Excite Medical of Tampa Bay, LLC
510(k) numberK243366
Submission
- Device name
- DRX9000C-SL Cervical Spinal Decompression System
- Applicant
- Excite Medical of Tampa Bay, LLC
Tampa, FL, US - Received
- October 28, 2024
- Decision date
- June 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITH – Equipment, Traction, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5900
- Specialty
- Physical Medicine
Other 510(k)s with product code ITH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL)ITH · Traditional | Excite Medical of Tampa Bay, LLC | 07/18/2025SE |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracITH · Traditional | Ergo-Flex Technologies, LLC | 02/22/2024SE |
| K222912 | c1TracITH · Traditional | Zimmer Medizinsysteme GmbH | 05/16/2023SE |
| K151640 | Eltrac 471ITH · Traditional | Enraf-Nonius, B.V. | 10/16/2015SE |
| K150695 | ModpodITH · Traditional | Hollywog, LLC | 08/13/2015SE |
| K131983 | Itrac Cervical Traction SystemITH · Traditional | Pivotal Health Solutions | 09/10/2014SE |
| K130249 | Integrity Spinal Care System 3.0ITH · Traditional | Integrity Life Sciences | 02/06/2014SE |
| K112074 | Everyway Traction Unit, Model Ever-Trac ET-800ITH · Traditional | Everyway Medical Instruments Co.,Ltd | 02/01/2012SE |
| K103248 | Integrity Spinal Care SystemITH · Traditional | Integra Life Sciences | 04/05/2011SE |
| K101889 | Decompression of Choice and Neuro Decompression DeviceITH · Traditional | Pivotal Health Solutions | 08/27/2010SE |
More from Pivotal Health Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL)ITH · Traditional | 07/18/2025SE |
Questions and answers
When was DRX9000C-SL Cervical Spinal Decompression System cleared by the FDA?
DRX9000C-SL Cervical Spinal Decompression System (K243366) received a 510(k) decision of Substantially Equivalent on June 18, 2025, 233 days after the submission was received.
What is the product code of K243366?
The FDA product code is ITH – Equipment, Traction, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5900.