QEF
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pressure Ulcer Management Tool
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.2100
- Medical specialty
- Gastroenterology, Urology
- 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 users decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.
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| Record | Firm | Date |
|---|---|---|
| SEM Scanner (Model 200) (DEN170021) | Bruin Biometrics, LLC | 2018-12-20 |
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