Pressure Ulcer Management Tool
The Pressure Ulcer Management Tool is a prescription device intended for patients at risk of developing pressure ulcers, providing output that supports a user's decision to increase intervention; it is an adjunct tool for pressure ulcer management and is not intended for detection or diagnostic purposes. It is classified as FDA Class 1, with no premarket notification required, under regulation 876.2100 in the Gastroenterology and Urology specialty. The product code is QEF. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QEF
- Device Class
- FDA class 1
- Regulation Number
- 876.2100
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN170021 | SEM Scanner (Model 200) | Dec 20, 2018 | Unknown | Bruin Biometrics, LLC |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.