Product Alert
Recently we have been getting alot of inquiries regarding hyperbaric chambers that are made both inside and outside the USA with no warranty and more importantly no FDA approval and or FDA compliance.
The IHA strives on bringing our members the latest update on these issues. With the rise in attention that Hyperbaric Therapy is getting it is even more imperative now to make our members and consumers aware of these chambers that are being illegally solicited in the USA.
These companies bring a great risk not only to the field but more so to the patients who are using them. The IHA is fully cooperating with current investigations going on with these illegal hyperbaric chambers. If you have any questions and or concerns relating to the hyperbaric chambers listed below please contact us at skenitz@ihausa.org
NON FDA Approved Chambers being sold illegally in the USA
1. Macy – Pan – these chambers also do private labeling so chambers may not say Macy – Pan on the outside but are still very much illegal in the USA.
The International Hyperbarics Association (IHA) strives to remain objective in promoting the use of soft-sided or portable hyperbaric chambers, that can be operated in the comfort of one’s residence. The most paramount aspect for all hyperbaric chambers is to be FDA approved.
It has recently come to the attention of the IHA that a company titled “AirSoak” is marketing and selling hyperbaric chambers in the USA without FDA approval. Under federal law, selling prescriptive medical devices to the public without a valid FDA 510 (k) clearance letter is a felony.
Moreover, AirSoak claims to have a soft-sided chamber model that can operate at 1.5 atmospheres. Marketing and selling a soft-sided chamber above 1.3 atmospheres is also breaking a very strict FDA regulation.
Additionally, AirSoak claims to have an office in New York, however, their phone number on their website is in Canada and they do not have a valid business license in the US nor are they incorporated. The address for AirSoak has shown to be a PO Box, which furthers concerns of the legitimacy of their business. Furthermore, the IHA’s legal counsel has identified that AirSoak does not have insurance coverage in the event of any major malfunction of their equipment.
The IHA is issuing this product alert to encourage everyone to ask for a hyperbaric chamber company’s FDA 510 (k) letter. If any chamber brand cannot produce this imperative document, we strongly recommend not to consider purchasing a chamber from that brand.