Box, Battery, Rechargeable
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- Huizhou Hizorion Tech Co., Ltd. Guangdong
How Is FCO Classified?
Box, Battery, Rechargeable is FDA product code FCO, Class 1, 21 CFR 876.1500.
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.