QEFClass I
Pressure Ulcer Management Tool
21 CFR 876.2100 / Gastroenterology, Urology
QEF is the FDA product code for Pressure Ulcer Management Tool, a class I device type, regulated under 21 CFR 876.2100. FDA's definition for this code reads: "A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QEF
- Device name
- Pressure Ulcer Management Tool
- FDA definition
- A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.
- Regulation
- 21 CFR 876.2100
- Device class
- Class I
- Review panel
- Gastroenterology, Urology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QEF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
Applicants with the most clearances
Product code QEF| Applicant | Clearances |
|---|---|
| Bruin Biometrics, LLC | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.