Data / Medical devices / Head Halter, Traction / United States
FDA-registered makers of Head Halter, Traction in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Head Halter, Traction (product code IRS). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Head Halter, Traction
- Product code
- IRS
- Country
- United States
Makers of Head Halter, Traction in the United States
| 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 | |
| Core Products Intl., Inc. | Osceola, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabrication Ent., Inc. | Elmsford, NY, United States | 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 |
Updated November 2, 2026. 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.