---
kind: "section"
citation: "21 C.F.R. § 878.5650"
title: "21"
number: "878.5650"
heading: "Topical oxygen chamber for extremities."
url: "https://uscodex.org/cfr/21/878.5650"
---

# §878.5650. Topical oxygen chamber for extremities.

- (a) **Identification.** A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.
- (b) **Classification.** Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See [§ 878.1(e)](/cfr/21/878.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[76 FR 22807, Apr. 25, 2011]

### Authority

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

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.

### Amendments

[76 FR 22807, Apr. 25, 2011]