Binder, Breast

Who Makes This Device Type in China?

3 of the 7 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Zhejiang, Guangdong and Jiangsu, and 2 other provinces.

Dalian Sportech Apparel Co., Ltd. Liaoning, contract manufacturer
Foshan Nanhai Jianli Underwear Co., Ltd. Guangdong, contract manufacturer
Lingxian Dongsheng Textile Co., Ltd. Shandong, contract manufacturer
Ningbo MPF Manufacturing Co., Ltd. Zhejiang, contract manufacturer
Shaoxing Intai Garment Co., Ltd. Zhejiang
Viecura Medical Group Limited Jiangsu, contract manufacturer
Zhejiang Rehan Medical Manufacturing Co., Ltd. Zhejiang

What Is FDA Product Code HEF?

Binder, Breast is FDA product code HEF, Class 1, 21 CFR 880.5160.

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.

Binder, Breast