Attachment, Narrowing, Wheelchair
Who Makes This Device Type in China?
2 of the 5 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Guangdong and Zhejiang.
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Jiangsu Sintang Health&Technology Co., Ltd. Jiangsu
- Permobil (Kunshan) Co., Ltd. Jiangsu
- Permobil Trading (Kunshan) Co., Ltd. Jiangsu, contract manufacturer
- Zhongshan Saxin Electric Heating Technology Co., Ltd. Guangdong
What Is FDA Product Code IMQ?
Attachment, Narrowing, Wheelchair is FDA product code IMQ, Class 1, 21 CFR 890.3920.
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.
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