Aid, Vision, Optical, Ac-Powered

Who Makes This Device Type in China?

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

Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) Shaanxi, contract manufacturer
Wenzhou Topsight Eyewear Co., Ltd. Zhejiang

What Is FDA Product Code HPI?

Aid, Vision, Optical, Ac-Powered is FDA product code HPI, Class 1, 21 CFR 886.5915.

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.

Aid, Vision, Optical, Ac-Powered

MedCenter 5000 Wall Mounted Set F.O./E56, US

Catalogue number 02.85020.002, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Aid, Vision, Optical, Ac-Powered. 2 manufacturers in China are registered for this product code.

Aid, Vision, Optical, Ac-Powered

MedCenter 5000 Wall Mounted Set, Ear Funnels Module

Catalogue number 02.84001.002, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Aid, Vision, Optical, Ac-Powered. 2 manufacturers in China are registered for this product code.

Aid, Vision, Optical, Ac-Powered

Who Makes This Device Type in China?

What Is FDA Product Code HPI?

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

MedCenter 5000 Wall Mounted Set F.O./E56, US

MedCenter 5000 Wall Mounted Set, Ear Funnels Module

Where China Actually Supplies