Support, Scrotal, Therapeutic
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Shanghai, and 2 other provinces: 9 hold an FDA registration. 1 is a contract manufacturer.
- AID United International Co., Limited Shanghai
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Meiguan Care Products Technology Co., Ltd. Jiangsu
- Dongguan NAN YOU Sporting Goods Enterprise Ltd Guangdong, contract manufacturer
- Dongguan Supercare Medical Products Co., Ltd. Guangdong, contract manufacturer
- Planet(Shanghai) International Co., Ltd. Shanghai
- Winning Industrial Co., Ltd. Guangdong, contract manufacturer
- Xiamen Chengli Medical Equipment Co., Ltd. Fujian
- Zhejiang Cathaya Health Care Devices Co., Ltd. Zhejiang, contract manufacturer
How Is FQJ Classified?
Support, Scrotal, Therapeutic is FDA product code FQJ, Class 1, 21 CFR 880.5820.
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.