Cabinet, Moist Steam
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Zhejiang and Anhui, and 1 other province: 8 hold an FDA registration. 1 is a contract manufacturer.
- Hefei Morningstar Healthmate Fitness Co., Ltd. Anhui
- Huaian Mimir Electric Appliance Co., Ltd. Jiangsu, contract manufacturer
- Hangzhou Wellbeing Technology Co., Ltd. Zhejiang, contract manufacturer
- Shenzhen Obestec Industrial Co., Ltd. Guangdong
- Sunplus LED Technology Co., Ltd. Guangdong
- Yiwu Vifa Imp.&Exp. Co., Ltd. Zhejiang
- Zhejiang Dingda Industrial Co., Ltd. Zhejiang
- Zhongshan Kingdom Electrical Appliance Co., Ltd. Guangdong
How Is IMB Classified?
Cabinet, Moist Steam is FDA product code IMB, Class 2, 21 CFR 890.5250.
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 Do the Recalls Say?
The FDA has recorded 5 recalls under this product code since 2007. None was by a company in China. The root cause the FDA records most often is Device Design (5).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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