Armboard, Wheelchair
Who Makes This Device Type in China?
6 of the 14 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Guangdong, Jiangsu and Zhejiang, and 2 other provinces.
- Anhui Yibao Home Textile Co., Ltd. Anhui
- China Wonderland Nurserygoods Co., Ltd. Guangdong
- Chiaphua Components (Jiangxi) Limited Jiangxi, contract manufacturer
- Feishen Group Co., Ltd. Zhejiang, contract manufacturer
- Guangdong Marshell Electric Vehicle Co., Ltd. Guangdong, contract manufacturer
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Kunshan Hi-Fortune Health Products Co., Ltd. Jiangsu, contract manufacturer
- Merits Healthcare Industries. (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
- Ningbo Gaobo Sports Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Ningyuan Import & Export Co., Ltd. Zhejiang, contract manufacturer
- Permobil (Kunshan) Co., Ltd. Jiangsu
- Permobil Trading (Kunshan) Co., Ltd. Jiangsu, contract manufacturer
- Viscount HI-Tech (Huizhou) Co., Ltd. Guangdong, contract manufacturer
- Zhongshan Saxin Electric Heating Technology Co., Ltd. Guangdong
How Is IMY Classified?
Armboard, Wheelchair is FDA product code IMY, Class 1, 21 CFR 890.3910.
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.