General Wellness Product
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Shanghai.
What Is This Device?
General wellness product as detailed in the guidance for purposes of imports only: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm429674.pdf
How Is PWC Classified?
General Wellness Product is FDA product code PWC, not classified.
How Does It Reach the US Market?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Do the Recalls Say?
The FDA has recorded 3 recalls under this product code since 2019. None was by a company in China. The root cause the FDA records most often is Packaging (2).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.