WARNING LETTER
Shenzhen Moyeah Intelligent Life Technology Co.
MARCS-CMS 677092 —
August 08, 2024
Reference #:
CPT2100342
Product:
Medical Devices
Recipient:
Recipient Name
Tingjun Yan
Recipient Title
Executive Director/Owner
Shenzhen Moyeah Intelligent Life Technology Co.
(b)(4)
Shenzhen Shi
Guangdong Sheng
,
518100
China
(b)(6)
(b)(6)@fda-registered.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 677092
August 8, 2024
Refer to: CPT2100342
Dear Tingjun Yan:
The United States Food and Drug Administration (FDA) has learned that your firm is offering for sale in the United States the following products without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act):
o CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP With Sanitizer Bag Ozone Disinfector C966|Latest Technology
o CPAP Cleaner And Sanitizer Mini Portable Cleaning Kit For Resmed Respironics Tube And Mask
o MOYEAH Mini Travel CPAP Cleaner Sanitizer With Disinfector Sterilizer Bag
o Moyeah CPAP Cleaner Ozone Disinfector C966 With Big Battery 2200mAh or Latest CPAP Cleaner Ozone Disinfector C966 With 2200mAH Big Battery – Moyeah Best CPAP/BIPAP Cleaner 2021
o MOYEAH UVC Cleaner Sanitizer Bag | CPAP Machine Cleaner Disinfector Bag
o 2023 Moyeah Latest UV Sterilizer Box & Ozone Disinfector Bag Oxygen Breathing Sleep Apnea Cleaner Bag With FDA By MOYEAH
o Mini Travel Cpap Cleaner And Sanitizer With CPAP Travel Bag For Resmed Respironics Tube And Mask
o CPAP Cleaner and Sanitizer Disinfector with Tube Adapters Hose Connectors For Cleaning CPAP Machine Mask Hose or Moyeah Portable Respiratory Breathing CPAP Machine Cleaner and Sanitizer – FDA Approved or Moyeah Portable CPAP Cleaner and Sanitizer Disinfector with Tube Adapters Hose Connectors for Cleaning CPAP Machine Mask Hose
o Rescomf Cpap Cleaner Sanitizer With Two adaptors For Resmed Respironics
o Moyeah Mini Portable Travel CPAP Cleaning Kit For Resmed Respironics Tube And Mask| Supplies CPAP Machines & Cleaners.
o MOYEAH UVC CPAP Sanitizer Bag for Cleaning | CPAP Cleaner and Sanitizer Bag for CPAP Machine, Accessories, Tubes & Mask
Under section 201(h) of the Act, 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
FDA has reviewed the labeling for your devices on your websites, http://moyeahstore.com and http://moyeahcpap.com (last visited June 04, 2024), and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. The above listed devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered the devices into interstate commerce for commercial distribution without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.
On your firm’s websites, your devices are described as using ozone/activated oxygen, or ultraviolet (UV) or the combination of ozone and UV to disinfect and sterilize CPAP therapy devices and CPAP accessories, and your websites include the following claims:
CPAP Cleaner With Sanitizer Bag Ozone Disinfector C966 or MOYEAH Brand New CPAP With Sanitizer Bag Ozone Disinfector C966|Latest Technology “Sterilization rate of 99.99% safely and naturally with no water or messy chemicals needed.” CPAP Cleaner and Sanitizer Mini Portable Cleaning Kit for Resmed Respironics Tube and Mask
o “Can easily connect to all brands of resmed, respironics CPAP, APAP Bi-PAP, VPAP, or BPAP machine tube, mask for sterilizer cleaning.”
o “USING OZONE STERILIZATION: Eliminates 99.9 percent of CPAP bacteria, germs, and other pathogens safely and naturally with no water or messy chemicals needed.”
MOYEAH Mini Travel CPAP Cleaner Sanitizer With Disinfector Sterilizer Bag
o “USING OZONE STERILIZATION: Eliminates 99.9 percent of CPAP bacteria, germs, and other pathogens safely and naturally with no water or messy chemicals needed.”
o “AUTOMATED CLEANING AND SAVES TIME:Cleaning kit cycle about 30minutes by ozone and completely automated cleaning cycle saves time by doing all the work for you.”
Moyeah CPAP Cleaner Ozone Disinfector C966 With Big Battery 2200mAh or Latest CPAP Cleaner Ozone Disinfector C966 With 2200mAH Big Battery – Moyeah Best CPAP/BIPAP Cleaner 2021
o “Sterilization rate of 99.99% safely and naturally.”
MOYEAH UVC Cleaner Sanitizer Bag | CPAP Machine Cleaner Disinfector Bag
 “CPAP Sanitizing Bag for Cleaning machines mask and tubing disinfection bag.” 2023 Moyeah Latest UV Sterilizer Box & Ozone Disinfector Bag Oxygen Breathing Sleep Apnea Cleaner Bag With FDA By MOYEAH
o “360 UVC lead sterilizer and ozone disinfection bag can kill 99.99% of Staph E. Coli, Salmonella, and other harmful bacteria.”
Mini Travel Cpap Cleaner And Sanitizer With CPAP Travel Bag For Resmed Respironics Tube And Mask
o “Can easily connect to all brands of resmed, respironics CPAP, APAP Bi-PAP, VPAP, or BPAP machine tube, mask for sterilizer cleaning.”
o “Our cpap cleaner and sanitizer is waterless, using ozone sterilization Kills 99.99% of germs and bacteria in your CPAP/APAP/BIPAP machine in only 30 minutes.”
o “USING OZONE STERILIZATION: Eliminates 99.9 percent of CPAP bacteria, germs, and other pathogens safely and naturally with no water or messy chemicals needed.”
CPAP Cleaner and Sanitizer Disinfector with Tube Adapters Hose Connectors For Cleaning CPAP Machine Mask Hose or Moyeah Portable Respiratory Breathing CPAP Machine Cleaner and Sanitizer – FDA Approved, also referred to as Moyeah Portable CPAP Cleaner and Sanitizer Disinfector with Tube Adapters Hose Connectors for Cleaning CPAP Machine Mask Hose
o “Sterilization rate of 99.99% safely and naturally with no water or messy chemicals needed.”
Rescomf Cpap Cleaner Sanitizer With Two adaptors For Resmed Respironics
o “Harnesses the power of ozone, which reacts 3,000 times faster than chlorine, Ensuring safety and cleanliness of your hose, mask, Cushion and CPAP machine & reservoir.”
o “99.9% EFFECTIVE at eradicating germs, mold and fungi from CPAP machines, tubing, masks, and humidifier chamber.”
Moyeah Mini Portable Travel CPAP Cleaning Kit For Resmed Respironics Tube And Mask| Supplies CPAP Machines & Cleaners.
o “Our cpap cleaner and sanitizer is waterless,using ozone sterilization Kills 99.99% of germs and bacteria in your CPAP/APAP/BIPAP equipment in only 30 minutes.”
o “USING OZONE STERILIZATION: Eliminates 99.9 percent of CPAP bacteria, germs, and other pathogens safely and naturally with no water or messy chemicals needed.”
MOYEAH UVC CPAP Sanitizer Bag for Cleaning | CPAP Cleaner and Sanitizer Bag for CPAP Machine, Accessories, Tubes & Mask
o “UVC CPAP Sanitizer Bag for Cleaning|CPAP Cleaner and Sanitizer Bag for CPAP Machines Accessories Like Tubing, Mask.”
o “The best CPAP cleaner and sanitizer UVC Bag online”
On May 26, 2021, the FDA sent a letter to the US agent for Shenzhen Moyeah Intelligent Life Technology Co that the MOYEAH products appear to meet the definition of a device under the FD&C Act and that they do not appear to be Class I exempt medical devices. FDA sent follow-up emails on March 3, 2023, and April 21, 2023, noting that pictures and/or content on your website continued to show that you were marketing your products as CPAP cleaner/sanitizer devices. To date, you have not responded to our correspondence.
Our office requests that Shenzhen Moyeah Intelligent Life Technology Co. cease any activities that result in the misbranding or adulteration of the above devices such as the commercial distribution of the devices for the uses discussed above.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent by email to: CDRHWarningLetterResponses@fda.hhs.gov or by mail to
Food and Drug Administration
Center for Devices and Radiological Health
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66
10903 New Hampshire Ave.
Silver Spring, MD 20993
Refer to the identification number CMS 677092 or CPT2100342 when replying. We remind you that only written communication is considered as official. If you have any questions about the contents of this letter, please contact: Dr. Bifeng Qian at: bifeng.qian@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm. It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA.
Sincerely yours,
/S/
Binita S. Ashar, MD, MBA, FACS
Director
OHT4: Office of Surgical and Infection Control
Devices Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
08/28/2024
Regulated Product(s)
Medical Devices