How Is IKY Classified?
Mattress, Flotation Therapy, Non-Powered is FDA product code IKY, Class 1, 21 CFR 880.5150.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.
What Do the Recalls Say?
The FDA has recorded 11 recalls under this product code since 2009. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Employee error (2) and Material/Component Contamination (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.