FDA product code ITH: Equipment, Traction, Powered
ITH is the FDA product code for equipment, traction, powered. It is a Class II device, regulated under 21 CFR 890.5900 and reviewed by the Physical Medicine panel. FDA has cleared 71 510(k) submissions under ITH, 4 in the last five years, from 59 different applicants. The average 510(k) review took 133 days (median 90); 509 days on average over the last three years. FDA has posted 5 recalls for ITH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Equipment, Traction, Powered |
| Device class | Class II |
| Regulation | 21 CFR 890.5900 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ITH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 232 |
| 2024 | 1 | 791 |
| 2025 | 2 | 227 |
Compare with all 510(k) review times · Search every ITH clearance
Top ITH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Excite Medical of Tampa Bay, LLC | 2 | 2025-07-18 |
| Pivotal Health Solutions | 2 | 2014-09-10 |
| Ito Co., Ltd. | 2 | 2008-08-25 |
| North American Medical Corp (Nam) | 2 | 2008-04-03 |
| Axiom Worldwide, Inc. | 2 | 2006-05-26 |
54 more applicants have ITH clearances. See the full list in Caduvo.
Most recent ITH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243775 | Excite Medical of Tampa Bay, LLC | True Non-Surgical Spinal Decompression System (DRX9000-SL) | 2025-07-18 | 221 |
| K243366 | Excite Medical of Tampa Bay, LLC | DRX9000C-SL Cervical Spinal Decompression System | 2025-06-18 | 233 |
| K214037 | Ergo-Flex Technologies, LLC | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | 2024-02-22 | 791 |
| K222912 | Zimmer Medizinsysteme GmbH | c1Trac | 2023-05-16 | 232 |
| K151640 | Enraf-Nonius, B.V. | ELTRAC 471 | 2015-10-16 | 120 |
Recalls for ITH devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-04-29.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code ITH?
ITH is the FDA product code for equipment, traction, powered. It is a Class II device, regulated under 21 CFR 890.5900 and reviewed by the Physical Medicine panel.
What device class is ITH?
Class II, regulation 21 CFR 890.5900. Typical premarket route: 510(k).
How long does a 510(k) take for product code ITH?
Across 71 cleared submissions the average was 133 days from receipt to decision (median 90).
Which companies have the most ITH clearances?
Excite Medical of Tampa Bay, LLC (2); Pivotal Health Solutions (2); Ito Co., Ltd. (2); North American Medical Corp (Nam) (2); Axiom Worldwide, Inc. (2).
Have ITH devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2024-04-29.
Next steps
- Run an FDA pathway report with predicate devices for product code ITH
- Run a recall and safety report across every ITH manufacturer
- Watch product code ITH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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