QEF · Pressure Ulcer Management Tool
Gastroenterology, Urology · 21 CFR 876.2100 · Class 1
Overview
| Product Code | QEF |
|---|---|
| Device Name | Pressure Ulcer Management Tool |
| Regulation | 21 CFR 876.2100 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN170021 | SEM Scanner (Model 200) | Bruin Biometrics, LLC | Dec 20, 2018 | DENG |
Top Applicants
- Bruin Biometrics, LLC — 1 clearance
