Raised Toilet Seat Without Arms
Catalogue number 10361, listed by Dynarex Corp., United States, under Adaptor, Hygiene. 193 manufacturers in China are registered for this product code.
193 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Zhejiang and Jiangsu, and 13 other provinces. 23 of them are contract manufacturers, able to build to a buyer’s own specification.
Adaptor, Hygiene is FDA product code ILS, Class 1, 21 CFR 890.5050.
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.
The FDA has recorded 4 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (2), Device Design (1) and Process design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Catalogue number 10361, listed by Dynarex Corp., United States, under Adaptor, Hygiene. 193 manufacturers in China are registered for this product code.
Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.