Zdrowie i gospodarka · 13/10/2015

FDA Reclassifies Shortwave Diathermy as Nonthermal Shortwave Therapy, Classifying it as Class II Device

The Food and Drug Administration (FDA) has issued a final order to reclassify shortwave diathermy (SWD) for all uses other than therapeutic purposes into Class II, requiring special controls, and renamed it as nonthermal shortwave therapy (SWT). The FDA also made a technical correction to the regulation for carrier frequency of SWD and SWT devices.