What is the truth about oxygen concentrators and hyperbaric chambers? The FDA has not approved ANY mild, soft-sided hyperbaric chamber to use with additional oxygen. This is true. 

Reputable manufacturers and resellers of hyperbaric chambers cannot sell their hyperbaric chambers with oxygen concentrators. The FDA does not allow this.  Why should you care? Because if these companies are willing to break the law with the FDA in such a major area, what guarantee do you have that they will "do right" by you? You can't throw them in jail - the FDA can, yet companies like Healing Dives completely disregard the law and rip off customers left and right.

The Healing Dives Hyperbaric Chamber/ OGSI Oxygen Concentrator Rip-off

RIP OFF PART 1:
When Diane Pechenick, the one-woman-show that does business under the name “Healing Dives,” sells you a hyperbaric chamber with an oxygen concentrator, she has you sign a paper stating that you have been informed that hyperbaric chambers are not approved by the FDA to use with oxygen.  Then she sells both the hyperbaric chamber AND the OGSI Oxygen Concentrator (OG15, OG20, or OG22, OG30H) to be used together. In the complexities of her mind, Diane Pechenick believes that she is now free from any legal responsibilities.  It is like the drug dealer who sells crack, but tells buyers “this is illegal, you shouldn’t smoke crack.” While both may be breaking the law, the FDA goes after the dealer, since OXYGEN is governed as a drug - it can be dangerous when used incorrectly.

 

So, now that Healing Dives has tried to force the responsibility for purchasing onto you, the consumer, then there is no reason for Diane, the owner, to obey any form of regulatory/safety mandates.  To summarize, she doesn’t feel obligated to sell you a real medical grade concentrator. In her opinion, a waste treatment, ozone, metal fabrication concentrator is just as good (and a hellava lot cheaper for her to purchase).  What’s really strange is that there are plenty of FDA approved portable oxygen concentrators that can be used with hyperbaric chambers that sell for the same price.  She must make better money on this one, because it is not designed for human use.  What a piece of work.

Check in tomorrow to see the emails she sends regarding this matter.  It is interesting to see her dance around this subject.
 


Comments

Katcoven
12/12/2011 12:03

Thank you for alerting us all to this potential problem. I also called the FDA and a couple of lawyers...and OGSI. The problem is..no one has tried to get approval yet for the mild chamber WITH the concentrator - the ONLY reason there is no clearance. The testing and safety data do exist to prove these units ARE more than acceptable for human use, and within a pressurized environment.

However, for a manufacturer to sell to a client who is also purchasing (past or present)a hyperbaric chamber, the physician must write "with oxygen" on the prescription. Not all people can use oxygen , hyperbarics, or a combination, so the physician must put his stamp of approval on the purchase. This is only when purchasing with a chamber. Otherwise, anyone can purchase an oxygen concentrator and use it for whatever they wish. Additionally, one of the indications for use for the OG-15 and OG-20 IS HYPERBARICS....it is on their website!!!!!

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RMDenver
12/12/2011 13:43

Katcoven, you sound like a reseller of these chambers/concentrators - like someone who is trying to cover their tracks. All you resellers use the same verbal "slight-of-hand".

You are using an old magician's trick called "redirect" - as in you are redirecting people to focus on the fact that mild hyperbaric chambers have not been approved to be used with added oxygen. YOU ARE TRICKING PEOPLE INTO IGNORING THE TRUTH: THE OG15 and OG20 ARE WASTE TREATMENT CONCENTRATORS NOT FDA APPROVED FOR HUMAN USE. THERE ARE OTHER OXYGEN CONCENTRATORS OUT THERE THAT HAVE BEEN APPROVED FOR HUMAN USE by the FDA that many people do use with their hyperbaric chambers. I have the list DIRECTLY FROM THE FDA.

Here is the link to the FDA database:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?start_search=1&Panel=&ProductCode=CAW&KNumber=K&Model=&Applicant=&DeviceName=&Type=&ThirdPartyReviewed=off&ClinicalTrials=off&ExpeditedReview=&Decision=&DecisionDateFrom=&DecisionDateTo=&IVDProducts=off&CombinationProducts=off&PAGENUM=10&SortColumn=DecisionDateDESC . No mention of the OGSI concentrators.

May I remind you that OGSI doesn't advertise them for human use either:
http://www.hyperbarics.info/uploads/7/0/2/4/7024192/og-2020112010.pdf

SO NICE TRICK, BUT WE ARE NOT FALLING FOR IT!

Reply
Katcoven
12/12/2011 23:25

Perhaps we all sound the same because it is the truth....I don't think you have spoken to a lawyer but you should.

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