Board, Bed
Which Manufacturers in China Make This?
3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Hebei and Jiangsu.
- Hebei Junlaole Medical Technology Co., Ltd. Hebei
- Jiangyin Huashi Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
- Zhongshan Saxin Electric Heating Technology Co., Ltd. Guangdong
How Is FPS Classified?
Board, Bed is FDA product code FPS, Class 1, 21 CFR 880.6070.
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.
What Do the Recalls Say?
The FDA has recorded 4 recalls under this product code since 2003. None was by a company in China. The root cause the FDA records most often is Component design/selection (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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Record