Zdrowie i gospodarka · 23/03/2015

FDA Classifies Limited Output Transcutaneous Piezoelectric Stimulator for Insect Bite Reactions into Class II (Special Controls)

The Food and Drug Administration (FDA) is classifying the limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites into Class II (special controls) to ensure the device is safe and effective. The special controls will be part of the codified language for the device's classification.