Data / Medical devices / Head Halter, Traction
Head Halter, Traction (IRS): 21 FDA-registered makers in 6 countries
21 establishments in 6 countries are registered with the FDA to make Head Halter, Traction (product code IRS, Class 1, 21 CFR 890.5925). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on July 11, 1977, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- IRS
- Device class
- 1
- Regulation
- 890.5925
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 9 |
| United States | 6 |
| India | 3 |
| Mexico | 1 |
| Taiwan | 1 |
| South Korea | 1 |
Makers of Head Halter, Traction
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 |
|---|---|---|---|---|---|---|---|---|
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aetas Corporation | Berwick, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amis (xiamen) Cultural Creativity Co., Ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cixi Cijia Handicraft Co. Ltd | Cixi Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products Intl., Inc. | Osceola, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Redthera Technology Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabrication Ent., Inc. | Elmsford, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Good Horse Toys And Gifts Co.ltd | DONGGUAN Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Leamai Medical Instrument Co., Ltd. | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neomed Co., Ltd. | Saha-gu Busan, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Alps Medical Technology Co., Ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Castle Medical Import & Export Co.,ltd | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pivotal Health Solutions | Watertown, SD, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Longstar Medical Equipment Co.,ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan City, Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 11, 1977. 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.