21 CFR 876.2100 — Pressure Ulcer Management Tool
Gastroenterology, Urology (GU) · Subpart C—Monitoring Devices · § 876.2100
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QEF | Pressure Ulcer Management Tool | 1 | 1 |
