StacksVerified U.S. regulatory reference

21 CFR §868.5470

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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).
  2. (b)Classification. Class II (performance standards).