Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy
Information
Type
Rule
Regulated products
Published
October 13, 2015
Last updated
October 13, 2015
Description
Document number 2015-25923. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)