Data / Medical devices / Pressure Ulcer Management Tool
Pressure Ulcer Management Tool (QEF): 5 FDA-registered makers in 3 countries
5 establishments in 3 countries are registered with the FDA to make Pressure Ulcer Management Tool (product code QEF, Class 1, 21 CFR 876.2100). 1 of them has 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 December 20, 2018, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QEF
- Device class
- 1
- Regulation
- 876.2100
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Mexico | 2 |
| South Korea | 1 |
Makers of Pressure Ulcer Management Tool
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 |
|---|---|---|---|---|---|---|---|---|
| Bruin Biometrics, LLC | Los Angeles, CA, United States | Manufacturer, Specification developer | 1 | December 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Emma Healthcare Co., Ltd. | Seongnam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polimeros Formula de Tecate S.A de C.V | Tecate Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 20, 2018. 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.