ITH · Equipment, Traction, Powered
Physical Medicine · 21 CFR 890.5900 · Class 2
Overview
| Product Code | ITH |
|---|---|
| Device Name | Equipment, Traction, Powered |
| Regulation | 21 CFR 890.5900 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 71)
Showing 20 most recent of 71 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | Jul 18, 2025 | SESE |
| K243366 | DRX9000C-SL Cervical Spinal Decompression System | Excite Medical of Tampa Bay, LLC | Jun 18, 2025 | SESE |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | Feb 22, 2024 | SESE |
| K222912 | c1Trac | Zimmer Medizinsysteme GmbH | May 16, 2023 | SESE |
| K151640 | ELTRAC 471 | Enraf-Nonius, B.V. | Oct 16, 2015 | SESE |
| K150695 | Modpod | Hollywog, LLC | Aug 13, 2015 | SESE |
| K131983 | ITRAC CERVICAL TRACTION SYSTEM | Pivotal Health Solutions | Sep 10, 2014 | SESE |
| K130249 | INTEGRITY SPINAL CARE SYSTEM 3.0 | Integrity Life Sciences | Feb 6, 2014 | SESE |
| K112074 | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 | Everyway Medical Instruments Co.,Ltd | Feb 1, 2012 | SESE |
| K103248 | INTEGRITY SPINAL CARE SYSTEM | Integra Life Sciences | Apr 5, 2011 | SESE |
| K101889 | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE | Pivotal Health Solutions | Aug 27, 2010 | SESE |
| K091540 | MTD 4000 | Mettler Electronics Corp. | Oct 8, 2009 | SESE |
| K081247 | TM-400 | Ito Co., Ltd. | Aug 25, 2008 | SESE |
| K072064 | GRAVILAX TRACTION SYSTEM | Therapeutic Clinical Technologies, Inc. | Apr 21, 2008 | SESE |
| K073132 | MODEL D DISC FORCE | North American Medical Corp (Nam) | Apr 3, 2008 | SESE |
| K073542 | CYCLETRAC CT-5000 | Pt Products, LLC | Feb 14, 2008 | SESE |
| K071347 | VAX-D GENESIS G2 SYSTEM | Vax-D Medical Technologies, LLC | Oct 5, 2007 | SESE |
| K063353 | CTBOX CERVICAL/LUMBAR TRACTION | Circular Traction Supply, Inc. | Mar 14, 2007 | SESE |
| K060735 | DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM | Axiom Worldwide, Inc. | May 26, 2006 | SESE |
| K053223 | TRITON/TRU-TRAC/TX/TRITON DTS TRACTION | Chattanooga Group | Feb 24, 2006 | SESE |
Top Applicants
- Axiom Usa., Inc. — 2 clearances
- Axiom Worldwide, Inc. — 2 clearances
- Cert Health Sciences, LLC — 2 clearances
- Chattanooga Group — 2 clearances
- Ever Prosperous Instrument, Inc. — 2 clearances
