Data / Medical devices / Equipment, Traction, Powered
Equipment, Traction, Powered (ITH): 16 FDA-registered makers in 8 countries
16 establishments in 8 countries are registered with the FDA to make Equipment, Traction, Powered (product code ITH, Class 2, 21 CFR 890.5900). 14 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 71 510(k) clearances under this code, the latest on July 18, 2025, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ITH
- Device class
- 2
- Regulation
- 890.5900
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Taiwan | 2 |
| Japan | 2 |
| Mexico | 1 |
| Netherlands | 1 |
| Canada | 1 |
| Germany | 1 |
| South Korea | 1 |
Makers of Equipment, Traction, Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Excite Medical Of Tampa Bay LLC | Tampa, FL, United States | Manufacturer | 4 | May 26, 2006 | 0 | 0 | 0 | api.fda.gov |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 3 | February 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| North American Medical Corporation | Marietta, GA, United States | Manufacturer | 3 | September 9, 2005 | 0 | 0 | 0 | api.fda.gov |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer | 2 | February 24, 2006 | 0 | 0 | 0 | api.fda.gov |
| Pivotal Health Solutions | Watertown, SD, United States | Complaint file establishment, Manufacturer | 2 | September 10, 2014 | 0 | 1 | 0 | api.fda.gov |
| Enraf-Nonius B.V. | ROTTERDAM Zuid-Holland, Netherlands | Complaint file establishment, Manufacturer, Specification developer | 1 | October 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Everyway Medical Instruments Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 1 | February 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Hollywog, LLC | Chattanooga, TN, United States | Manufacturer | 1 | August 13, 2015 | 0 | 0 | 0 | api.fda.gov |
| Hill Laboratories | Frazer, PA, United States | Manufacturer | 1 | December 22, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ito Co., Ltd. | Kawaguchi Saitama, Japan | Specification developer | 1 | August 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| ITO CO., LTD. Tsukuba Factory | Inashiki-Gun Ibaraki, Japan | Manufacturer | 1 | August 25, 2008 | 0 | 0 | 0 | api.fda.gov |
| Universal Pain Technology Canada Inc. | PRINCE GEORGE British Columbia, Canada | Manufacturer | 1 | April 27, 2005 | 0 | 0 | 0 | api.fda.gov |
| Zimmer Medizinsysteme GMBH | NEU-ULM Bavaria, Germany | Manufacturer | 1 | May 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zmi Electronics Ltd. | Kaohsiung, Taiwan | Manufacturer | 1 | October 8, 2009 | 0 | 0 | 0 | api.fda.gov |
| JM Tech, Ltd. Co. | Incheon, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zober Industries, Inc. | Croydon, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.