Evoked Photon Image Capture Device
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Jiangsu.
What Is It?
The System reports two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and sweat on the image and one without the capacitive barrier. The response scale reports numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions.
This device is only to be used to image and document electrophysiological signals emanating from the skin.
What Is FDA Product Code PNA?
Evoked Photon Image Capture Device is FDA product code PNA, Class 1, 21 CFR 882.1561.
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.