FDA 510(k)

The TANGO3 Water Storage Tank with Ozone Disinfection System has been assigned FDA 510(k) 093641

Ozone Info

The virtue of ozone

Although ozone has been successfully used for disinfection for over 100 years, there is so much misunderstanding about how and why it works and questions about its safety.  I hope to sufficiently address those concerns in this communication.  I have also provided, separately, a comprehensive explanation as to how the Tango system functions to provide the benefits of ozone efficiently and safely. 

Ozone is a triatomic oxygen molecule, formed by an electrical discharge that causes some of the oxygen molecules (O2) to split apart and attach to other oxygen molecules, forming ozone (O3).  The brisk, fresh, clean smell in the air after a thunder storm is a result of ozone.  It kills odors.  It also kills bacteria, viruses and fungi far more effectively than anything else available for that purpose.  It decomposes rapidly (reverting to oxygen), which means no hazardous chemical residue to deal with, and no expensive chemicals to buy.  It is a remarkably “green” technology.

Concerns about possible harmful levels of ozone in the air have been addressed by including an ozone scavenging system that is integral to the Tango system and explained in the description provided.

We recognized that most dialysis facilities had PVC plumbing in place and they would be resistant to tearing it out as a condition of buying the Tango system.  We also knew that the PVC in place had been exposed to sodium hypochlorite (bleach), peracetic acid, and, for many facilities, both products were used to try to control the problem.  As part of our submission to FDA, we submitted results of testing to demonstrate that ozone was compatible with PVC piping systems that had previously been exposed to sodium hypochlorite and peracetic acid.  There was no leaching or degradation of the PVC.   We also proved that ozone would reduce biofilm over time.  This means, of course, that using ozone regularly would prohibit the formation of biofilm.

Again, ozone is the most effective germicidal agent available in the marketplace and is the strongest oxidizer on the planet useful for water disinfection.  I hope this information has been helpful to you in your understanding of ozone.  I encourage you to read the functional description of the Tango system as well, then call and discuss any questions you may have with me, or my technical manager, Fred Spencer.

 

Hugh Doss

President/CEO