(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]