Table, Operating-Room, Mechanical

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Shanghai and Jiangsu: 3 hold an FDA registration.

Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
Shanghai Huifeng Medical Instrument Co., Ltd. Shanghai, contract manufacturer
Shanghai PAX Medical Instrument Co., Ltd. Shanghai

How Is FWX Classified?

Table, Operating-Room, Mechanical is FDA product code FWX, Class 1, 21 CFR 878.4950.

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.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2008. None was by a company in China. The root cause the FDA records most often is Labeling design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Table, Operating-Room, Mechanical

Klyo

Mobile, operating tables (Mechanical Operating Tables, Hydraulic Operating Tables) designed to be adjusted to support a patient during many types of surgical interventions. The table…

Table, Operating-Room, Mechanical

Multilok Table Base

Catalogue number 0302-001, listed by Mizuho Orthopedic Systems, Inc., United States, under Table, Operating-Room, Mechanical. 3 manufacturers in China are registered for this product code.

Table, Operating-Room, Mechanical