---
kind: "section"
citation: "21 C.F.R. § 876.2100"
title: "21"
number: "876.2100"
heading: "Pressure ulcer management tool."
url: "https://uscodex.org/cfr/21/876.2100"
---

# §876.2100. Pressure ulcer management tool.

- (a) **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.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to the limitations in [§ 876.9](/cfr/21/876.9.md).

## Notes

### Amendments

[86 FR 70735, Dec. 13, 2021]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[86 FR 70735, Dec. 13, 2021]