Legality of Modifying a Chamber
The recent increase in the number of reports regarding the modification of chambers is a great cause of alarm. With over 10 years of experience building hyperbaric chambers and having over 7000 chambers in circulation, OxyHealth, LLC is universally recognized as the authority in the field of soft-chamber portable hyperbarics, and they are currently in an all-out effort to put an end to it.
Modifying a soft chamber is both illegal and potentially harmful!
A portable hyperbaric chamber is a prescriptive device regulated by the FDA. OxyHealth, LLC facilities have been audited by the FDA and their procedures meet stringent requirements. Their commitment to safety has helped produce a chamber that has been in fact "over-built." Even still, it should NEVER be modified in anyway to withstand pressures beyond that approved by the FDA.
When a chamber is modified, the FDA considers it “adulterated” and it immediately loses its 510K clearance (the FDA’s safety compliance approval for medical devices). After spending time and money to purchase an FDA-regulated quality chamber, all those assurances are stripped away, and your investment is completely compromised. It would be like purchasing a medical-grade oxygen concentrator, then swapping it for a welder’s concentrator – the assurance for human consumption is gone and any use of the product would be suspect.
To continue to use an adulterated prescriptive device is illegal. If a practice is found to be using a modified chamber, it can be shut down and the person(s) found using that chamber may be prosecuted as well as held personally liable. It is perceived by the “law” that you have combined two items in an illegal manner – similar to the drunk driver that mixes excess alcohol consumption with driving. The car manufacturer or distillery is not arrested – just the driver.
Because a chamber is a physical device, some people falsely believe that there is no real harm in making a modification to it. However, this modification is viewed by the FDA as being just as illegal as modifying Sudafed to produce crystal meth. You may get instructions and an adaptation kit over the internet from someone working out of a rented garage, but please think twice.
If you have an issue with the FDA those people who provided the adaptation equipment would be the first to disappear, taking no accountability for the problem they created.
The risk to yourself and family is just not worth it.