FDA WARNING_LETTER - Shenzhen Moyeah Intelligent Life Technology Co. - August 08, 2024

The FDA issued a Warning Letter to Tingjun Yan of Shenzhen Shi Guangdong Sheng, China, regarding several CPAP cleaner and sanitizer products offered for sale in the United States. The FDA determined these products are devices under section 201(h) of the Act and are being marketed without the required premarket clearance or approval. Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). Additionally, the devices are misbranded under section 502(o) of the Act for being introduced into interstate commerce without submitting a premarket notification (510(k)) to the FDA. The firm's websites, moyeahstore.com and moyeahcpap.com, describe the devices as using ozone/activated oxygen or UV to disinfect and sterilize CPAP therapy devices, making various sterilization claims. The FDA had previously corresponded with the firm's US agent in 2021, 2023, and April 2023, noting the continued marketing of these products as CPAP cleaner/sanitizer devices, but received no response. The FDA requests the firm cease activities resulting in the misbranding or adulteration of these devices and provide a written response within fifteen business days detailing corrective actions, a plan to prevent recurrence, and a timetable for implementation.