Hemorrhoid Prevention Pressure Wedge
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong.
- Dong Guan JIA Shuan Industrial Co., Ltd. Guangdong
- Picard Healthcare Technology (Dongguan) Co., Ltd. Guangdong, contract manufacturer
What Is It?
Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.
How Is OOA Classified?
Hemorrhoid Prevention Pressure Wedge is FDA product code OOA, Class 2, 21 CFR 884.5200.
How Does It Reach the US Market?
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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