21 CFR § 878.5650 - Topical oxygen chamber for extremities.

---
identifier: "/us/cfr/t21/s878.5650"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.5650 - Topical oxygen chamber for extremities."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.5650"
section_name: "Topical oxygen chamber for extremities."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---


# 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) for the availability of this guidance document.

[76 FR 22807, Apr. 25, 2011]