CPAP cleaners get warning 

WASHINGTON – Four companies have received warning letters from the U.S. Food and Drug Administration for selling CPAP cleaning products without marketing clearance or approval, violating the Federal Food, Drug and Cosmetic Act. 

The companies are: 

• Shenzhen Moyeah Intelligent Life Technology Co. for 10 different products, including the CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP Sanitizer Bag Ozone Disinfector C966|Latest Technology. 

• Natures Pillow and Top Dog Direct for its Clean Zone CPAP Sanitizer. 

• Adventure Innovations for its Sani Bot D3. 

• LEEL Technology for its CLYN (CZ001 & CLYN Universal), LEEL and SOLID (Solid CPAP & ONECLICK SOLID) devices. 

The FDA requests that the companies cease any activities that result in the misbranding or adulteration of the devices, such as the commercial distribution of the devices, and respond to the agency within 15 days.  

The FDA initially sent a letter to Shenzhen in May 2021 and then again in March and April 2023 and, to date, has not received a response. 

The agency also initially sent a letter to Natures Pillow and Top Dog Direct responded in May 2021 and the company responded that it is exempt from premarket notification requirements as a Class I device under 21 CFR 880.6890, general purpose disinfectants, in June 2021. The agency says the company’s response is inadequate. 

The FDA initially sent a letter to Adventure Innovations in September 2022 and then again in March and April. The company responded that it did not agree with the agency’s assessment in April 2023 and again in May 2023. 

The agency initially sent a letter to LEEL Tech in May 2023. The company responded in August and November saying that it was an “agent for CPAP cleaner machines” and does not directly provide or manufacture the devices. The agency says the company’s response is inadequate.