Water Immersion Labor Pool
Which Manufacturers in China Make This?
2 manufacturers in China hold an FDA registration for this device type, based in Guangdong.
- Boluo County Longhua Chang FA Plastic Co., Ltd. Guangdong
- Dongguan Ellian Enterprise, Ltd. Guangdong, contract manufacturer
What Is It?
Partial water immersion during labor in hospitals, birth centers and home.
How Is OVX Classified?
Water Immersion Labor Pool is FDA product code OVX, not classified.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
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