Fed Regist. 2015 Oct 13;80(197):61298-302.
The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device "nonthermal shortwave therapy'' (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices.
美国食品药品监督管理局(FDA)正在发布一项最终命令,将所有其他用途的短波透热疗法(SWD,一种修正案前的III类设备)重新分类为II类(特殊控制),并将该设备重新命名为“非热短波疗法”(SWT)。FDA还对SWD和SWT设备的载波频率规定进行了技术修正。