Data / Medical devices / Plinth
Plinth (INT): 8 FDA-registered makers in 5 countries
8 establishments in 5 countries are registered with the FDA to make Plinth (product code INT, Class 1, 21 CFR 890.3520). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on July 11, 1977, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- INT
- Device class
- 1
- Regulation
- 890.3520
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Israel | 1 |
| China | 1 |
| Denmark | 1 |
| United Kingdom | 1 |
Makers of Plinth
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 |
|---|---|---|---|---|---|---|---|---|
| Baxter Healthcare - Aviv | Tel Aviv, Israel | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hausmann Enterprises, LLC | Northvale, NJ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Sintang Health&technology Co.,ltd | Yancheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pressalit | Ry Midtjylland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seers Medical Ltd | Debenham Suffolk, United Kingdom | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tri W-G, Inc. | Valley City, ND, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trumedical Solutions, LLC. | Ooltewah, TN, United States | Contract manufacturer, 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.