Code of Federal Regulations (Last Updated: April 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 878 - General and Plastic Surgery Devices |
Subpart F - Therapeutic Devices |
§ 878.5650 - Topical oxygen chamber for extremities.
Latest version.
-
§ 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]