Cuff, Pusher, Wheelchair
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Jiangxi, and 2 other provinces: 11 hold an FDA registration. 4 are contract manufacturers.
- China Wonderland Nurserygoods Co., Ltd. Guangdong
- Chiaphua Components (Jiangxi) Limited Jiangxi, contract manufacturer
- Feishen Group Co., Ltd. Zhejiang, contract manufacturer
- Global Fabtech Wheel Chair (Shanghai) Co., Ltd. Shanghai, contract manufacturer
- Guangdong Hexin Technology Weaving Co., Ltd. Guangdong, contract manufacturer
- Guangdong Marshell Electric Vehicle Co., Ltd. Guangdong, contract manufacturer
- Kunshan Hi-Fortune Health Products Co., Ltd. Jiangsu, contract manufacturer
- Merits Healthcare Industries. (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
- Permobil (Kunshan) Co., Ltd. Jiangsu
- Trolli King (Holding) Ltd. Guangdong, contract manufacturer
- Viscount HI-Tech (Huizhou) Co., Ltd. Guangdong, contract manufacturer
How Is INC Classified?
Cuff, Pusher, Wheelchair is FDA product code INC, Class 1, 21 CFR 890.3910.
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. It is also exempt from most of the quality system regulation.
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