(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 Sec. 878.1(e) for the availability of this guidance document. [76 FR 22807, Apr. 25, 2011]