Board, Arm (With Cover), Sterile

Who Makes This Device Type in China?

5 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Anhui and Zhejiang. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.

Boen Healthcare Co., Ltd. Jiangsu
Sino Protection (Hefei) Medical Products Co., Ltd. Anhui, contract manufacturer
Suzhou Meccan Import and Export Corp. Jiangsu, contract manufacturer
Yearstar Healthcare Technology Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Longterm Medical Technology Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code BTX?

Board, Arm (With Cover), Sterile is FDA product code BTX, Class 1, 21 CFR 878.3910.

What Does It Take to Sell It in the United States?

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.

Board, Arm (With Cover), Sterile