Kera®starSplint Bio
Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm
Splint, Temporary Training
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Fujian, Guangdong and Zhejiang, and 3 other provinces: 16 hold an FDA registration. 6 are contract manufacturers.
- BUY Asia Enterprise Ltd Guangdong
- Changzhou Well Lands Technology Co., Ltd. Jiangsu, contract manufacturer
- Cixi Cijia Handicraft Co., Ltd. Zhejiang, contract manufacturer
- Dongguan Suscong Healthcare Co., Ltd. Guangdong, contract manufacturer
- Dongguan Vigor Textile Co., Ltd. Guangdong, contract manufacturer
- Hengshui Xukang Medical Appliances Co., Ltd. Hebei, contract manufacturer
- Liven Sports MFG. (Xiamen) Co., Ltd. Fujian
- Ningbo MDC Import & Export Co., Ltd. Shanghai
- Orthotech Rehabilitation Co., Ltd. Fujian
- Shenzhen WAP-Health Technology Co., Ltd. Guangdong
- Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai, contract manufacturer
- Suzhou Kingstone Garments Co., Ltd. Jiangsu, contract manufacturer
- T&L (Jiaxing) Co., Ltd. Zhejiang
- Xiamen Bosegrow Medical Equipment Co., Ltd. Fujian
- Xiamen J-Brace Medical Equipment Co., Ltd. Fujian
- Zhejiang Rehan Medical Manufacturing Co., Ltd. Zhejiang
What Is FDA Product Code IQM?
Splint, Temporary Training is FDA product code IQM, 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.