ITH
- Product code
- ITH
- Device name
- Equipment, Traction, Powered
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5900
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 71 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243775 | 2025-07-18 | Excite Medical of Tampa Bay, LLC | True Non-Surgical Spinal Decompression System (DRX90… | |
| K243366 | 2025-06-18 | Excite Medical of Tampa Bay, LLC | DRX9000C-SL Cervical Spinal Decompression System | |
| K214037 | 2024-02-22 | Ergo-Flex Technologies, LLC | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Ce… |
Official FDA classification page: ITH
Classification and pathway per current FDA publications. Data from openFDA (CC0).