Data / Medical devices / Stimulator, Bone Growth, Non-Invasive / United States
FDA-registered makers of Stimulator, Bone Growth, Non-Invasive in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Stimulator, Bone Growth, Non-Invasive (product code LOF). 10 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Stimulator, Bone Growth, Non-Invasive
- Product code
- LOF
- Country
- United States
Makers of Stimulator, Bone Growth, Non-Invasive in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Djo, LLC | Vista, CA, United States | Manufacturer | 1 | September 29, 2026 | 2 | 0 | 0 | api.fda.gov |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 1 | September 29, 2026 | 2 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Manufacturer, Specification developer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Ebi Patient Care, Inc. | Guaynabo, PR, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Ebi, LLC | Parsippany, NJ, United States | Complaint file establishment, Specification developer | 0 | 2 | 1 | 0 | api.fda.gov | |
| Highridge Medical, LLC | Westminster, CO, United States | Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Bioventus LLC | Durham, NC, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Bioventus LLC | Cordova, TN, United States | Complaint file establishment, Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Theragen, Inc. | Jacksonville, FL, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Xstim Inc. | Irving, TX, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Clearlake-Tech Inc | Clear Lake, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEKO MedTec Solutions | Oakdale, PA, United States | Contract 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.