What Is This Device?
Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.
How Is PDH Classified?
Blanket, Neonatal Phototherapy is FDA product code PDH, Class 2, 21 CFR 880.5700.
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. The review can be done by an FDA-accredited third party, which is usually faster. 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 Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2014. None was by a company in China. The root cause the FDA records most often is No Marketing Application (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.