Boucher DeGroot Head Positioning Glasses
Reader, prism, ophthalmic (glasses)
Reader, Prism, Ophthalmic
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are based in Fujian and Zhejiang: 2 hold an FDA registration. 1 is a contract manufacturer.
- Dahong Optical (Xiamen) Co., Ltd. Fujian
- Wenzhou ZHI Cheng Optical Co., Ltd. Zhejiang, contract manufacturer
What Is FDA Product Code HJX?
Reader, Prism, Ophthalmic is FDA product code HJX, Class 1, 21 CFR 886.5810.
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. It is also exempt from most of the quality system regulation.
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