Device, Heimlich Maneuver Assist
Who Makes This Device Type in China?
3 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Zhejiang.
- Boen Healthcare Co., Ltd. Jiangsu
- Ningbo Hanyue Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Saferlife Products Co., Ltd. Guangdong, contract manufacturer
How Is MZT Classified?
Device, Heimlich Maneuver Assist is FDA product code MZT, Class 2, 21 CFR 868.5115.
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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