PNA · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.1561
Classification
FDA Product Code
PNA
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 882.1561
Review panel
NE
Medical specialty
Neurology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.