Does Exceeding 2 PSI Make a Hyperbaric Chamber a Medical Device?

Question

Accepted Answer

No—not by pressure alone. Exceeding 2 PSI may be important to engineering, code, safety, or operational analysis, but it is not a universal test for FDA medical-device status. FDA analysis considers intended use, claims, design, labeling, and other facts under applicable law. A chamber marketed for disease treatment may raise different questions from one presented for general wellness, regardless of a single pressure number.