21 C.F.R. § 868.5935
External negative pressure ventilator.
Cite as 21 C.F.R. § 868.5935 (2026)
(a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. (b) Classification. Class II (performance standards).