Pad, Kelly
Who Makes This Device Type in China?
5 manufacturers in China hold an FDA registration for this device type, concentrated in Shandong, Hubei and Jiangsu, and 1 other province. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
- Jiangsu Keling Medical Appliances Co., Ltd. Jiangsu, contract manufacturer
- Shandong Kangli Medical Equipment Technology Co., Ltd. Shandong
- Shanghai Dochem Industries Co., Ltd. Shanghai
- Wuhan Huaxin Nonwoven Co., Ltd. Hubei, contract manufacturer
How Is FNW Classified?
Pad, Kelly is FDA product code FNW, Class 2, 21 CFR 878.4370.
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.
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