FDA WARNING_LETTER - Adventure Innovations LLC - August 07, 2024

The FDA issued a Warning Letter to Evolution CPAP LLC (Re: Sani Bot D3, CMS # 676842) on August 7, 2024, for offering the Sani Bot D3 for sale in the U.S. without marketing clearance or approval. The FDA determined the Sani Bot D3 is a device under section 201(h) of the Act, intended for use in diagnosing, curing, mitigating, treating, or preventing disease, or affecting body structure/function.

The device is adulterated under section 501(f)(1)(B) because Evolution CPAP LLC lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) for being introduced into interstate commerce without a premarket notification (510(k)) as required by 21 CFR 807.81(a)(1).

The Sani Bot D3, marketed on Amazon.com, uses ultrasonic technology to clean CPAP devices and accessories, with claims like "Prevent congestion, and sickness," "Improves Sleep, Removes Congestion, Reduces Headaches." The FDA previously informed Adventure Innovations LLC (related to Evolution CPAP LLC) in September 2022 that the Sani-Bot D3 appears to be a medical device and not Class I exempt. Evolution CPAP LLC'