EasyShift
EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
Bed, Hydraulic, Adjustable Hospital
Who Makes This Device Type in China?
4 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Jiangsu.
- Foshan Maiteng Medical Technology Co., Ltd. Guangdong
- Foshan OST Medical Equipment Technology Co., Ltd. Guangdong, contract manufacturer
- Foshan Zubon Technology Co., Ltd. Guangdong
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code FNK?
Bed, Hydraulic, Adjustable Hospital is FDA product code FNK, Class 1, 21 CFR 880.5110.
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.
What Has Gone Wrong With It?
The FDA has recorded 4 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Process change control (2) and Device Design (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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