In brief: CPAP cleaners get warnings, ZOLL eyes Vyaire’s vent biz 

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. 

ZOLL wins rights to Vyaire’s vent biz 

CHELMSFORD, Mass. – ZOLL has announced it is the winning bidder in an auction to buy Vyaire Medical’s ventilator business as part of the company’s Chapter 11 bankruptcy proceedings. Completion of the acquisition is subject to court approval at a sale hearing and dependent on a successful closing that is anticipated to occur in the coming weeks. “Respiratory care has been central to ZOLL’s business strategy for many years,” said Jon Rennert, CEO of ZOLL. “If the acquisition is successfully completed, adding Vyaire’s ventilators to ZOLL’s product portfolio will enhance our ability to serve a broader range of clinicians and patients.” Vyaire Medical announced in June it had voluntarily filed for Chapter 11 bankruptcy protection in the U.S. The Chapter 11 filing allowed Vyaire to continue to operate while seeking to sell its business units, including the Vyaire ventilation business. ZOLL, an Asahi Kasei company, provides a comprehensive set of technologies, including defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, therapeutic temperature management, and sleep apnea diagnosis and treatment that help clinicians, EMS and fire professionals, as well as lay rescuers. 

Next Day Access expands to St. Louis 

ST. LOUIS – Next Day Access has opened a new franchise location in St. Louis. The franchise is owned and operated by Brian Liberman, who has a diverse background in finance, retail and commercial lending. “My mother was a quadriplegic, and I am very sympathetic to the needs of our clients," he said. "Next Day Access offers a business where we can feel good knowing that we have made a positive impact on our clients and their families. That sense of purpose and the opportunity to serve others in such a meaningful way drew me to this franchise." Prior to opening the franchise, Liberman worked as a certified public accountant (CPA), ran his family’s retail lighting business and served as a commercial lender. Next Day Access St. Louis will focus on providing accessibility and mobility solutions to individuals of all ages across St. Louis & Metro East. The company sells, delivers and installs accessibility and mobility products, such as wheelchair ramps, stairlifts, grab bars, wheelchair lifts, and more. Next Day Access was acquired by private equity-backed Best Life Brands earlier this year.