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FDA Proposes to Reclassify Shortwave Diathermy

02/20/2014

Federal Register Proposed order: FDA is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments Class 3 device, into Class 2 (special controls), and to rename the device “nonthermal shortwave therapy (SWT) ” The agency is proposing this reclassification on its own initiative based on new information and is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. To view this proposed order, click here.

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