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SoClean 3+ Automated Supplemental Sleep Equipment Maintenance System
Respiratory Accessory Microbial Reduction Device.
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Guangdong: 2 hold an FDA registration. 1 is a contract manufacturer.
- JDI Electronics Factory Guangdong, contract manufacturer
- Zhongshan Sunclean Co., Ltd. Guangdong
What Is This Device?
A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions.
How Is QXQ Classified?
Respiratory Accessory Microbial Reduction Device. is FDA product code QXQ, Class 2, 21 CFR 880.6993.
What Does It Take to Sell It in the United States?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
What Has Gone Wrong With It?
The FDA has recorded 2 recalls under this product code since 2023. None was by a company in China. The root cause the FDA records most often is Labeling design (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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