Tingjun Yan
Executive Director/Owner
Shenzhen Moyeah Intelligent Life Technology Co.
(b)(4)
Shenzhen Shi
Guangdong Sheng , 518100
China
(b)(6)Issued Aug 8, 2024Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.
Violations1
Issue DateAug 8, 2024
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Shenzhen Moyeah Intelligent Life Technology Co.
Location
Tingjun Yan
Executive Director/Owner
Shenzhen Moyeah Intelligent Life Technology Co.
(b)(4)
Shenzhen Shi
Guangdong Sheng , 518100
China
(b)(6)
FEI Number
N/A
Country
China
Issue Date
August 08, 2024
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Shenzhen Moyeah Intelligent Life Technology Co. was warned for offering multiple CPAP cleaner and sanitizer products for sale in the United States without required FDA marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. The products, including various ozone disinfectors, UV sterilizer bags, and portable cleaning kits marketed under the Moyeah brand, were classified as medical devices but were distributed without the necessary premarket authorization. The company's marketing claims—including references to "FDA Approved" in some product listings—further violated regulatory requirements by misrepresenting the regulatory status of unapproved devices.
Shenzhen Moyeah Intelligent Life Technology Co. FDA Warning Letter, August 8, 2024