The first hint that the email below was from a questionable source was that it started with “Dear my friend.” I received the email below about “mil” [sic] hyperbaric oxygen chambers. This manufacturer is illegally importing inflatable chambers into the USA. Even if they were being legally imported, they are not cleared for use with oxygen – which is a separate safety issue. It’s easy to find out if a specific chamber has been cleared by the FDA, and to report illegal activities to the FDA (keep reading). It only takes a few minutes.
Dear my friend,
We specialize in manufacturing top quality mil hyperbaric oxygen chambers, offering cutting-edge technology, durability, and competitive pricing. Our products are widely used in medical, sports, and wellness industries.
If you want to know more , please kindly back to us for a catalog?
Looking forward to your reply.
Best regards,
[Redacted]
First, to find out if a chamber is cleared by the FDA for use in the USA, go to the FDA 510k searchable database and in the product code box enter CBF. No other entries are needed. This will populate with every chamber (by manufacturer) that has been formally cleared by the FDA. See the screen capture that I made:
Here is the list of hyperbaric chambers that are cleared by the FDA. You can scroll through it to look for a specific manufacturer.
If you find that you have been solicited by a manufacturer who is not supposed to be marketing chambers in the USA, you can notify the FDA via the Form FDA 3500B. This is a mechanism that providers and individuals can report medical device concerns to the FDA. This should generate what is called a CPT file (read that as complaint file).
I have reported “my friend” and his “mil” chamber to the FDA.
–Caroline
Other Resources:
Dr. Fife is a world renowned wound care physician dedicated to improving patient outcomes through quality driven care. Please visit my blog at CarolineFifeMD.com and my Youtube channel at https://www.youtube.com/c/carolinefifemd/videos
The opinions, comments, and content expressed or implied in my statements are solely my own and do not necessarily reflect the position or views of Intellicure or any of the boards on which I serve.
