868.5470 Hyperbaric chamber.§ 868.5470 Hyperbaric chamber.
(a) Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (§ 878.5650).
(b) Classification. Class II (performance standards).