Can You Get And Use Soft HBOT Chambers of More Than 1.3ATA for Hyperbaric Treatments in the US?

This article was originally written by Marc Merlins on the marc.merlins.org

I’ll start this by staying, I’m not a doctor, I’m not a lawyer, I’m not a sales person, and I’m not a medical device medical engineer with FDA approval/regulations specialty, although I did use to live with one for over 10 years, so I have some understanding of that FDA process while not being a specialist on it either (but neither are most who talk about it). Before I continue, I’ll point out that multiple people who post about HBOT and call themselves doctors are not medical doctors with medical degrees, and therefore their medical background or opinion should be on the same level as mine. You should trust what I say no more than what they say, but hopefully I’m giving enough reasoned information below that matches what’s currently happening in the US market, that you can consider my points as hopefully valid.

Now that this is out of the way, I’ll summarize what I’ve read and seen, partially to help others, as well as encourage someone who actually knows this stuff inside and out, to tell me if I’m wrong, why, and show me supporting evidence like clear FDA regulations and how they apply to what I’m going to explain below. I will however say right now that I will only consider “you’re wrong” opinions with clear supporting evidence in a well written reply with references and ignore you if you say “I know this stuff, but I don’t have time to write the details as to why I’m right and you’re wrong”.

Read the entire article here…