QEF — Pressure Ulcer Management Tool Class I
FDA product code QEF covers "Pressure Ulcer Management Tool", a Class I medical device regulated under 21 CFR 876.2100. Submissions are reviewed by the Gastroenterology, Urology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QEF
- Device Class
- Class I
- Regulation Number
- 876.2100
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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 users decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN170021 | bruin biometrics | SEM Scanner (Model 200) | December 20, 2018 |