Legality of Modifying a Chamber
The Illegal Modification of a Chamber
The recent increase in the number of calls to our staff at OxyHealth, LLC, regarding the modification of chambers is a great cause of alarm to our company. 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.
Our acknowledged experience is the reason why many doctors, chiropractors, and other medical practitioners have brought their concerns to us regarding certain modifications to soft hyperbaric chambers that have been advanced on the internet.
Modifying your 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 our procedures meet their stringent requirements. Our commitment to safety has helped us to produce a chamber that has been well over-built. Even still, we would NEVER encourage any modification that would increase the amount of pressure 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 or a patient, 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 your patients is just not worth it.
Why at OxyHealth, LLC do we care what people do after they purchase a chamber?
We care because our friends and families use our chambers. We care because we have built long-term relationships with the professional and personal communities that rely on our chambers on a daily basis. After 10 years in this industry, we have built a reputation for quality, safety, and customer care that we are proud to maintain.
At OxyHealth, LLC, a team of over 50 “care” professionals stands behind every chamber. It is important to the physicians who rely on OxyHealth chambers for their practices and medical research, as well as to the very patients who use OxyHealth chambers.
We have worked diligently over the past 10 years and have delivered over 1.5 million treatments annually in OxyHealth chambers to confidently present to our customers their chamber at optimum operational condition.