Bed, Patient Rotation, Manual
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are based in Jiangsu and Hebei: 3 hold an FDA registration. 1 is a contract manufacturer.
- Hebei Healthplus Medical Device Co Ltd Hebei
- Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
- Jiangyin Newrise Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
What Is FDA Product Code INY?
Bed, Patient Rotation, Manual is FDA product code INY, Class 1, 21 CFR 890.5180.
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.
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