Helmet, Cranial, for Protective Use
Which Manufacturers in China Make This?
10 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Zhejiang and Jiangsu, and 1 other province. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Anhui Kangfu Industrial Foreign Trade Co., Ltd. Anhui, contract manufacturer
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Meiguan Care Products Technology Co., Ltd. Jiangsu
- Dongguan Redthera Technology Co., Ltd. Guangdong
- Guangdong Bole Sports Equipment Co., Ltd. Guangdong, contract manufacturer
- Ningbo Castle Medical Import & Export Co., Ltd. Zhejiang, contract manufacturer
- Ningbo MPF Manufacturing Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Ningyuan Import & Export Co., Ltd. Zhejiang, contract manufacturer
- Shenzhen Zhouyang Medical Care Product Co., Ltd. Guangdong, contract manufacturer
- Shenzhen reanson products Co., Ltd. Guangdong
What Is FDA Product Code NDA?
Helmet, Cranial, For Protective Use is FDA product code NDA, Class 1, 21 CFR 890.3025.
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.
What Has Gone Wrong With It?
The FDA has recorded 1 recall under this product code since 2006. None was by a company in China. The root cause the FDA records most often is Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.