Field Generator Positioning Device
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Shandong.
- Weihai Dishang Medical Technology Co., Ltd. Shandong, contract manufacturer
What Is It?
An accessory or a group of accessories that operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, to manually position the Field Generator of a Navigation System in proximity to a patient.
How Is QLV Classified?
Field Generator Positioning Device is FDA product code QLV, Class 1, 21 CFR 882.4565.
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.