Unit, Wrist, External Limb Component, Powered
Which Manufacturers in China Make This?
One manufacturer in China holds an FDA registration for this device type, based in Jiangsu.
- Yearstar Healthcare Technology Co., Ltd. Jiangsu, contract manufacturer
How Is KGH Classified?
Unit, Wrist, External Limb Component, Powered is FDA product code KGH, Class 1, 21 CFR 890.3420.
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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