Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy
other · Food and Drug Administration · Rule · Published 2015-10-13 · Effective 2015-10-13 · 80 FR 61298
Document
Document number
2015-25923
Federal Register citation
80 FR 61298
CFR reference
21 CFR 890
Type
Rule
Action
Final order; technical correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2015-10-13
Effective date
2015-10-13
HHS docket
Docket No. FDA-2012-N-0378
Abstract
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.