Treadmill, Mechanical
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- IPE Plastic & Hardware Industy, Ltd Guangdong, contract manufacturer
- Sunshine Healthcare Co., Ltd. Guangdong
What Is FDA Product Code IOG?
Treadmill, Mechanical is FDA product code IOG, Class 1, 21 CFR 890.5370.
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.
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