Cold Pack and Vibrating Massager
Who Makes This Device Type in China?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Fujian, and 2 other provinces: 18 hold an FDA registration.
- Dongguan Qianhe Electronic Technology Co., Ltd. Guangdong, contract manufacturer
- Guangdong Fuqiang Beauty Equipment Co., Limited Guangdong
- Guangzhou Konmison Technology Co., Ltd. Guangdong
- Hubei Xinyunqi Household Products Co., Ltd. Hubei
- Health Care Massage Branch of Zhangzhou Easepal Industrial Corporation Fujian
- IBE Electronics Co., Ltd. Guangdong
- Jiangsu Sintang Health&Technology Co., Ltd. Jiangsu
- Jiangsu World Biotech Co., Ltd. Jiangsu
- Shenzhen Beston E-Commerce Co., Ltd. Guangdong
- Shenzhen Eyco Technology Co., Ltd. Guangdong
- Shenzhen Ruiyi Business Technology Co., Ltd. Guangdong
- Shenzhen Saiote Intelligent Manufacturing Co., Ltd. Guangdong
- Shenzhen Shengbanghua Technology Development Co., Ltd. Guangdong
- Shenzhen Bway Tech Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Margotan Tech Co., Ltd. Guangdong
- Tianjin Tairuibosi Medical Appliance Co., Ltd. Tianjin
- Zhongshan Meiyigou Electronics Co., Ltd. Guangdong
- Zhongshan Bisen Plastic Electronic Products Co., Ltd. Guangdong, contract manufacturer
What Is This Device?
Relief of minor aches and pains, controlling the pain associated with needle sticks (injections, IV, venipuncture).
How Is PHW Classified?
Cold Pack And Vibrating Massager is FDA product code PHW, Class 1, 21 CFR 890.5975.
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.
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