federal_register: 2014-03594

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2014-03594 Physical Medicine Devices; Reclassification and Renaming of Shortwave Diathermy for All Other Uses Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify the 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 proposing this reclassification on its own initiative based on new information. FDA is also proposing a technical correction in the regulation for the carrier frequency for SWD and nonthermal SWT devices. This proposed action would implement certain regulatory requirements. 2014-02-20 2014 2 https://www.federalregister.gov/documents/2014/02/20/2014-03594/physical-medicine-devices-reclassification-and-renaming-of-shortwave-diathermy-for-all-other-uses https://www.govinfo.gov/content/pkg/FR-2014-02-20/pdf/2014-03594.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify the 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...

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