Stirrup, External Brace Component
Which Manufacturers in China Make This?
6 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Fujian and Taiwan. 1 of them is a contract manufacturer, able to build to a buyer’s own specification.
- Abletech Orthopedics Corporation Taiwan, contract manufacturer
- Dongguan Sava Sporting Products Co., Ltd. Guangdong, contract manufacturer
- Guangdong Hexin Technology Weaving Co., Ltd. Guangdong, contract manufacturer
- GuoLong (Shenzhen) High Technology Co., Ltd. Guangdong, contract manufacturer
- Zhangpu Ortholife Rehabilitation Co., Ltd. Fujian
- Zhangzhou Recaring Medical Instrument Co., Ltd. Fujian
How Is ITC Classified?
Stirrup, External Brace Component is FDA product code ITC, Class 1, 21 CFR 890.3410.
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. It is also exempt from most of the quality system regulation.