SimplyAir™ Regulatory Information
The SimplyAir BA825W and ST830W are authorized for distribution by the FDA in the US via an Emergency Use Authorization (EUA). There has been no indication from FDA at this time related to withdrawal of COVID-19 EUA's. According to the FDA's EUA Transition Guidance, the SimplyAir is considered a "reusable, non-life-supporting/non-life-sustaining device”. In the event where the EUA ends without any pending or issued 510(k), this product may remain in the market for the life of the product.
Movair will be directly managing and controlling the 510k process for the SimplyAir. Movair expects the 510(k) for SimplyAir will be submitted in Q4 2026.
Please note that SimplyAir is a Movair product, not a Löwenstein Medical product.
For more information on the FDA Guidance Document, you can use the link below:
The Choice is Simple:
The SimplyAir has been authorized by the FDA under an EUA but has not been FDA cleared or approved. The SimplyAir is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. U.S. federal law restricts this device to sale by or on the order of a physician.
