Heater, Perineal, Direct Contact
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- Shenzhen Kaiyan Medical Equipment Co., Ltd. Guangdong, contract manufacturer
How Is HGZ Classified?
Heater, Perineal, Direct Contact is FDA product code HGZ, Class 2, 21 CFR 884.5390.
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.
Name
Record