FitAir Full Kit

FitAir and FitAir accessories are Non-refundable due to masks and filtering systems being personal use items. Please consider carefully before purchasing.

“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 and smoke with the best ultralight air solution anywhere you go.

• LIVE HEALTHIER: Designed to help you breathe better and live healthier during your daily lifestyle routine. Whether you're traveling in your car or on a plane, running errands, or simply working at your desk, FitAir can be there with you. This air purifier comes with an easy-to-use strap that quickly attaches the device to your arm or backpack straps.
• HIGH VOLUME AIRFLOW: High porous inlets with 290 ports, allowing maximum airflow of 130 L/min (average adult breathing capacity is 10-20 L/min). It offers continuous cleaning for 25 square feet of space surrounding you. There are three-levels of airflow adjustments.

• FitAir is filtering the air with a true-medical grade H13 HEPA filter, which has 99.97% filtration efficiency.
• FitAir helps to keep airborne particles such as pollen outside of your mask. Masks have the challenge of adequately fitting and sealing at the sides since everyone's face size is different. FitAir's innovative design is a different way to help approach that issue.
• FitAir is much more breathable as it sends fresh clean air to your nose. You will have a more effortless breath of fresh air compared to other masks that can be difficult to breathe with.

• Battery Life: 2~6 h
• Power: 3W 1600 mAh
• Size: 7.2*3.5*3.1 inches
• Item Weight: 7.8 oz
• Shipping Weight: 1.05 pounds
• Accessory box (2 silicone tubes) will be shipped separately.

While, at the present time, FitAir is neither FDA nor NIOSH certified, our medical team is actively engaged in the application 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 benefit 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 therefore 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. 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 FitAir 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 recommend against use in a high risk aerosol generating 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: 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 130 Liters 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 medical articles have shown that using a PLAIN MASK can be dangerous for our bodies (see small list of Articles below):

1. Respirators used by healthcare workers INCREASE  Carbon Dioxide (that is the BAD oxygen). Levent, Ozdemir, J Clin Anesth.2020;
2. Physiological impact of the N95 filter face piece respirator on healthcare workers. (FINDINGS: Wearing a plain N95 Mask leads to INCREASED Carbon Dioxide (that’s the bad oxygen) and DECREASED Oxygen levels (that’s the good Oxygen). Roberge-RJ, Resp Care 2010
3. Objective assessment of increase in breathing resistance of N95 Respirators. (FINDINGS: 126% increase in inspiratory resistance, 122% increase in expiratory resistance and 37% reduction in air exchange volume!!!) FIRST study to show this!! Heow Pueh Lee, Ann Occup Hyg. 2011
4. Carbon Dioxide (bad oxygen)rebreathing in respiratory devices: Influence on speech and work rate. (FINDINGS: wearing a standard respirator leads to rebreathing of Carbon Dioxide (bad oxygen) which leads to low work rates. Carmen Smith, Ergonomics. 2013
5. N95 filtering facepiece respirator dead space temperature and humidity. (FINDINGS: after just 1 Hour, regular N95 mask dead space temperature and humidity were markedly elevated) Raymond Roberge, J Occup Envir Hyg 2012
6. Headaches and the N95 Face Mask amongst healthcare providers. (FINDINGS: healthcare providers may develop headaches with regular N95 masks ) ECH Lim Acta Neurol Scand 2006

Q: Wait, I’m confused. So what happens when I wear a regular mask or even a more protective plain N95 Mask?

1. Your Carbon Dioxide (bad Oxygen) goes up. That’s bad!
2. Your Oxygen (good oxygen) goes down. That’s bad!
3. Your work of breathing is harder as it faces more resistance!
4. The temperature and humidity in our mask is greatly elevated!
5. You will probably develop a headache!

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 looks 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:

1. Accuracy and reliability of pulse oximetry at different arterial carbon dioxide pressure levels. (FINDINGS: As your carbon dioxide (bad oxygen) goes up (as shown in the articles above) the pulse oximeter can overestimate the true oxygen saturation. X Munoz, Eur Resp J. 2008
2. Effects of non-functional hemoglobin on oxygen saturation measurements. (FINDINGS: the greater the presence of non functioning hemoglobin (like that in smokers) the falser the pulse oximeter reading. Phillis Pulse Oximetry Handbook
3. Accuracy of pulse oximetry during hypoxemia. (FINDINGS: As hypoxemia (good oxygen decreases) gets more pronounced, the accuracy of the pulse oximeter drops. D Thrush South Med J 1994

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 1^st 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 2^nd 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 to this date of a healthcare worker infecting someone else with their mask. Please see study below:

1. What proportion of healthcare worker masks carry virus? (FINDINGS: NO strong evidence to support the assumption that mask use may increase the risk of viral transmission). Peter Jones Emergency Medicine Australasia, 2020

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 used 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