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FDA registered – Ultramasx’s new smart mask is revolutionary

January 15, 2021 3 min read

Ultramasx announces their new flagship product, the Ultramasx UltraOne respirator, is FDA registered and approved to use by the general public and healthcare personnel.


According to the World Health Organization, 7 million people die from air pollution each year. Face masks have become a necessity for humans all over the world. Many people are searching for the best face masks on the market that can protect them and give them enough ventilation.  One companyhasbeen revolutionizing the market with a smart mask since 2019. 

Ultramasx Technologies started their journey in 2019 when founder and CEO Ivan Simetovic visioned to protect people from air pollution, viruses, smog, and bacteria. Since then FDA registered Ultramasx Technologies has developed their flagship product, the Ultramasx UltraOne respirator. UltraOne is an electrically ventilated smart mask and even more revolutionary since the pandemic, Covid-19 broke out in 2020.

What makes UltraOne so good?

UltraOne has been engineered to protect humans by giving them a long-lasting, breathable, comfortable, and eco-friendly mask design. It is great for everyday use as well as people traveling on airplanes or local commuting.  Below are some of the greatest advantages of the UltraOne.


The UltraOne is a rechargeable device that can be charged via USB. It is also reusable with the refill filters that the company provides. What’s great about the UltraOne is that it lasts for years making it much more sustainable, cost- and eco-friendly than disposable or cloth masks or. The battery life of the UltraOne lasts for up to 8 hours. 


UltraOne is built for comfort and was invented with a medical-grade silicone face seal, as well as thin straps that have limited contact with the skin. The UltraOne’s slick design makes it very comfortable for people wearing glasses and eliminates any fogging of the glasses when worn. 


Protection is what it is all about, and the reason for this product being so effective is the ultra-protection it offers consumers. The UltraOne has state-of-the-art 4 stage HEPA as well as ultra-fine activated carbon filter cartridge. With this technology, it removes more than 99.97% of suspended particles above PM0.3 equivalent to a KN100/N100/FFP3 rating. This smart-mask does not only protect the wearer as the UltraOne includes an exhaust air filter protecting the people surrounding them. 


The UltraOne has a built-in active 2-speed electric turbofan that provides optimal air-flow resulting in better breathability compared to a passive textile mask of the same filtration grade. The smartrespirator provides consumers with 6.9 cubic meters per hour of purified and fresh air making it suitable for people to wear it when doing sports. It also leaves consumers with a refreshing feeling on humid, warm days.

What do the people say?

Consumers love this new inventive product, some have even described it as the ‘Cadillac’ of the face mask world. They described it as light as paper of a normal cloth face mask and have reviewed that the fan is not loud at all. The UltraOne also has many five-star ratings on Amazon. The product has even been featured on the New York Post, ABC, Fox News, NBC as well as USA Today but also on the frequent flyer magazines of American Airlines and Singapore Airlines.

Ultramasx UtraOne is registered with the U.S. Food and Drug administration with listing numbers D432175 and D432516 as respirators and surgical face masks for general public/healthcare personnel per IIE guidance. One of the company’s biggest achievements is being registered by the FDA. This tells us, along with consumers, that their products are reliable and up to health standards. 

“We have been working night and day in the last 12 months and the U.S. FDA registration is a great milestone for our company.” says CEO and Founder Ivan Simetovic “I want to thank all our partners, our team, our suppliers, and above all customers that helped us improve our products every day. We are working already on the next generation smart respirators, that on top of state-of-the-art filtration will also include connectivity. We are close to the American people and families and with this milestone we demonstrate our effort for them”