Konmed
It is a product can be used as medical purposes specified in Intended use and it is easy to wear and take off and with humanized design, which can be adjustableit is designed with below…
Device, Finger-Sucking
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Hubei and Jiangsu: 4 hold an FDA registration.
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Meiguan Care Products Technology Co., Ltd. Jiangsu
- Gauke (Hubei) Healthcare Co., Ltd. Hubei, contract manufacturer
- Gauke International Trading Co., Ltd. Hubei
What Is FDA Product Code LQX?
Device, Finger-Sucking is FDA product code LQX, Class 1, 21 CFR 890.3475.
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.
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