{"abstract":"The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.","action":"Final order.","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/2016/10/18/2016-25001.html","cfr_references":[{"chapter":null,"citation_url":null,"part":890,"title":21}],"citation":"81 FR 71610","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This order is effective October 18, 2016. The classification was applicable on May 9, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-2829"],"dockets":[],"document_number":"2016-25001","effective_on":"2016-10-18","end_page":71612,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/10/18/2016-25001.xml","html_url":"https://www.federalregister.gov/documents/2016/10/18/2016-25001/medical-devices-physical-medicine-devices-classification-of-the-upper-extremity-prosthesis-including","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-25001?publication_date=2016-10-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-10-18/2016-25001/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1206,"last_updated":"2026-08-05 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-18/pdf/2016-25001.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-25001.pdf?1476708333","publication_date":"2016-10-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/10/18/2016-25001.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-2016-N-2829","supporting_documents_count":0,"docket_id":"FDA-2016-N-2829","regulation_id_number":null,"title":"Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components","checked_regulationsdotgov_at":"2016-11-07T06:00:22Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71610,"subtype":null,"title":"Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components","toc_doc":"Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components","toc_subject":"Medical Devices:","topics":["Medical devices"],"type":"Rule","volume":81}