Device, Acupressure
Which Manufacturers in China Make This?
4 manufacturers in China hold an FDA registration for this device type, based in Guangdong and Hebei. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Dongguan Sheng Yan Industrial Co., Ltd. Guangdong, contract manufacturer
- Shijiazhuang Aofeite Medical Device Co., Ltd. Hebei
- Tung Hing Plastic & Metal(Shenzhen) Co., Ltd. Guangdong, contract manufacturer
- Vastrade Manufacturing Corporation Guangdong, contract manufacturer
What Is FDA Product Code MVV?
Device, Acupressure is FDA product code MVV, unclassified.
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.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2007. None was by a company in China. The root cause the FDA records most often is PMA (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
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