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“Once 80% of the population wears a mask, the outbreak can be stopped immediately.”
——2019 Study Published in the U.S. National Library of Medicine
Free your air of allergens, smoke with the best ultralight air solution anywhere you go.
While, at the present time, FitAir is neither FDA nor NIOSH certified, our medical team is actively engaged in the apllication process. However due to the covid-19 pandemic, there is a tremendous backlog in the application office and major delays are to be expected. We, thus, after years of research and development,have opted to bring FitAir to market now, so that all may benifit from its use.
FitAir was originally designed to help protect consumers from hazardous, yet "normal" conditions such as dust, air pollution, fumes, smog, etc.! FitAir, is truly unique, in the fact that is offers 2 points of air filtration (the hepa filter on the device as well as the mask the consumer wears). Furthermore, there is no leakage and there is no outflow (of exhaled air) and therefre there is no contamination to any bystander(s) and those around are not infected. Normal cleaning of FitAir can be done by washing its parts with soap and water, using UV light, or even with a hot air blow dryer.
Due to the pandemic the FDA currently does not intend to object to the marketing and distribution of masks in a healthcare setting even if they are manufactured at facilities that do not meet CFR 820 and On April 18, 2020, in response to concerns relating to insufficient supply and availability of face masks, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) , a waiver, under which we believe Fit air qualifies for being made available to ALL Health Care professionals in need of its benefits.
To comply with this current FDA waiver we are making the following statements and we believe FitAir fits all of these criteria:
· This is not a surgical mask
· FitAir may be used as a source control device when FDA cleared masks are scarce or unavailable.
· We recommend against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected.
· We reccomend againt use in a high risk aerosol genersting procedure(s)
· We make no claims of antimicrobial or antiviral protection.
· We make no claims of infection prevention or reduction.
· We make no claims regarding flammability.
· The product has not been FDA cleared or approved
· The product has been authorized by FDA under an EUA for use as source control by the general public as well as by HCP in healthcare settings as to help prevent the spread of infection or illness during the COVID-19 pandemic.
· This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner
As per the waiver statement, Health Care Professionals include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).
Q: Safe for use for Coronavirus?
A: A this time, we CANNOT make such a statement. Although our medical in the process of obtaining testing reports for use against Coronavirus at the present time we do not have any. The HEPA filter used by FitAir is a TRUE HEPA filter which has been certified to remove 95% of 0.3 micron contaminants ( HEPA filter is compatible and equal in its properties with and N95Filter) Furthermore, FitAir is the only current portable device on the market which offers 2 filtering points of entry; the true HEPA filter (as mentioned above) and the KN95 mask supplied with the FitAir Device. So, in essence, you are doubly protected.
Q: Why do I need the air to be purified and Infused into my mask?
A: Normally every (averaged sized) human inhales around 5 Liters of air every minute. Unfortunately, ALL humans have something called Anatomical DEAD SPACE in our bodies. That just means we have “tubes” in our bodies (like the trachea or our windpipe), where air JUST sits there and DOES NOT participate in gas exchange in our lungs. This dead space is about 1.5 Liters. So, really ONLY 3.5 Liters of fresh air gets delivered to our lungs every minute. NOW, when you put on a REGULAR mask, there is now MORE dead space to be added on top our anatomical dead space; and that is the dead space between your face and the mask!. So even more bad air just is sitting there, not ventilated!. FitAir filters and infuses ,and refreshes continuously 130Liters of fresh purified air every minute. So that Dead Space now gets circulated , gets cleaned and thus more fresh air is brought to your lungs so you breathe so much better. You breathe better air, fresher air and cleaner air with FitAir than without it.
Q: So why should I care if I get more air infused? I’m breathing very well thank you with my plain mask.
A: Actually NUMEROUS published medicalarticles have shown that using a PLAIN MASKcan be dangerous for our bodies (see small list of Articles below):
Q: Wait, I’m confused. So what happens when I wear a regular mask or even a more protective plain N95 Mask?
Q: Wait one minute please. I see all these videos on social media, where a doctor ran a marathon with 7 masks on and the oxygen never went down, or another healthcare provider had on a N95 mask, a surgical mask and a cloth mask and the oxygen level did not go down. Explain that please.
A: Those videos unfortunately do not tell the whole truth. The ONLY device we have right now to easily measure Oxygenation is the Pulse Oximeter (please google it to see what it look like). Unfortunately, the pulse oximeter is TERRIBLE at accurately measuring the oxygen saturation and moreover the pulse oximeter FALSELY OVERESTIMATES oxygen saturation. Here are a few published medical articles that prove just this:
Q. Will I Contaminate anyone around me when I wear the FitAir?
A: ABSOLUTELY NOT! There is NO air leak from the FitAir at all, thus you CANNOT contaminate anyone. The FitAir’s 1st point of filtering is the true HEPA filter which “sucks” in the surrounding air, it filters it and purifies it and delivers it via its attached hose to your mask where then you inhale freshly purified filtered air. The 2nd point of filter is the N95 or KN95 mask which is on your face and that also filters the air you breathe. There is no air escape from the FitAir. Furthermore there has never been a documented case t this date of a healthcare worker infecting someone else with their mask. Please see study below:
Q: Do you sell replacement masks? And how many per pack if you do？
A: Yes. We do sell replacement masks. It's 10 in a box. But please remember that these masks are dedicated to being used together with the FitAir filter unit and should not be used independently. Also you can use other approved masks together with the FitAir filter unit as long as you cut a hole of our connector size on it.Our healthcare worker clients simply cut a hole that fits the FitAir tubing into their N95 masks and use it as such.
Q: So is it safe to use FitAir?
A: TO THIS DATE, WE DO NOT KNOW OF ANY HEALTHCARE WORKER WHO HAS WORN A FIT AIR WHO HAS BECOME SICK. We are preparing a research paper to document this and we shall make it available on this website when it will be published.
Q: I have more questions about the above? Who can I contact?
A: For general questions please contact our listed email contact but for medical questions pertaining to FitAir, please contact our medical director at: DrC@airdogusa.com