{"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.","action":"Final order; technical correction.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2015/10/13/2015-25923.html","cfr_references":[{"chapter":null,"citation_url":null,"part":890,"title":21}],"citation":"80 FR 61298","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective on October 13, 2015. See further discussion in Section IV, \"Implementation Strategy.\"","disposition_notes":null,"docket_ids":["Docket No. FDA-2012-N-0378"],"dockets":[],"document_number":"2015-25923","effective_on":"2015-10-13","end_page":61302,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/10/13/2015-25923.xml","html_url":"https://www.federalregister.gov/documents/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-diathermy-for-all-other-uses-henceforth-to","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-25923?publication_date=2015-10-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-10-13/2015-25923/mods.xml","not_received_for_publication":null,"page_length":5,"page_views":{"count":4972,"last_updated":"2026-07-25 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-10-13/pdf/2015-25923.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-25923.pdf?1444394805","publication_date":"2015-10-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/10/13/2015-25923.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2012-N-0378","supporting_documents_count":0,"docket_id":"FDA-2012-N-0378","regulation_id_number":null,"title":"Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses","checked_regulationsdotgov_at":"2015-11-02T06:00:13Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":61298,"subtype":null,"title":"Physical Medicine Devices; Reclassification of Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy","toc_doc":"Physical Medicine Devices; Shortwave Diathermy for All Other Uses, Henceforth To Be Known as Nonthermal Shortwave Therapy; Reclassification","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":80}