Four companies warned for selling unauthorized CPAP cleaners

The US Food and Drug Administration (FDA) has sent four warning letters to companies for selling continuous positive airway pressure (CPAP) machine cleaners online without proper marketing authorization.

While the companies claimed that their products are nearly 100% effective at sterilizing the machines, the agency said that none have not filed any premarket approval (PMA) applications or submitted premarket notifications to back up those claims.

On 7 and 8 August, the FDA sent warning letters to Shenzhen Moyeah Intelligent Life Technology, Natures Pillows and Top Dog Direct, Adventure Innovations, and LEEL Tech, reprimanding them for marketing the unauthorized CPAP cleaning products online on their own websites and on online retail platforms, such as Amazon.com. While the companies described their devices as cleaners, sterilizers, and sanitizers, FDA admonished them for lacking marketing authorization to sell the products.

Except for Adventure Innovations, FDA noted that the companies describe their devices as using ozone/activated oxygen, or ultraviolet (UV) or the combination of ozone and UV to disinfect and sterilize CPAP machines and their accessories. For Adventure Innovation's Sani Bot D3 CPAP cleaner, the agency pointed out that the company claims it uses ultrasonic transducer technology with a cleaning solution to deep clean CPAP machines and their accessories.

Three of the warning letters noted that the companies claimed that their products are 99% or 99.99% effective at cleaning CPAP machines, in some cases without using water or chemicals. The companies also claimed that their technologies can penetrate solid layers of CPAP machines to clean inaccessible surfaces. FDA said these claims have not been proven.

FDA noted that it sent letters to all four companies advising them that their products met the definition of a medical device beginning as early as 2021, but none of them adequately responded to the agency’s concerns. In the case of Shenzhen Moyeah, FDA said the company did not respond to any of its three prior correspondences before the warning letter was issued.

All the companies have been told to stop marketing their products and have been given 15 business days to respond to FDA’s warning letters.

Warning letters: Shenzhen Moyeah, Natures Pillows, LEEL Tech, Adventure Innovations

Four companies warned for selling unauthorized CPAP cleaners

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