{"id":168,"date":"2016-07-18T16:36:49","date_gmt":"2016-07-18T14:36:49","guid":{"rendered":"http:\/\/www.axilumrobotics.com\/ww2\/en\/?page_id=168"},"modified":"2023-03-03T22:22:44","modified_gmt":"2023-03-03T21:22:44","slug":"regulatory-information","status":"publish","type":"page","link":"https:\/\/www.axilumrobotics.com\/en\/regulatory-information\/","title":{"rendered":"Regulatory Information"},"content":{"rendered":"

1- TMS-Cobot<\/h2>\n

Regulations in the European Union<\/h3>\n

Axilum Robotics TMS-Cobot<\/b> is manufactured by Axilum Robotics<\/a>. It is a Class IIa medical device intended to automate the positioning of a Transcranial Magnetic Stimulation coil. It holds the CE mark whose conformity has been assessed by Notified Body SGS 1639<\/a>. Before any use, please read the user manual.<\/p>\n

 <\/p>\n

\"\"<\/a>\"icone_pdf\"\u00a0Download Axilum Robotics TMS-Cobot CE marking certificate.<\/a><\/p>\n

Regulations in the USA<\/h3>\n

Axilum Robotics TMS-Cobot<\/b> has 510(k) clearance from the FDA (Food and Drug Administration) in the USA (FDA clearance K182768 Class II). Axilum Robotics TMS-Cobot\u00ae TS MV is indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system.<\/p>\n

Regulations in Australia<\/h3>\n

Axilum Robotics TMS-Cobot<\/strong> has been approved in Australia by Therapeutic Goods Administration. Intended purpose : Robotic systems intended to automate and improve the accuracy and repeatability of the positioning of a Transcranial Magnetic Stimulation (TMS) coil, in the clinical situations where compatible TMS devices are intended to be used, with the exception of peripheral nerve stimulation.<\/p>\n

Regulations in Singapore<\/h3>\n

Axilum Robotics TMS-Cobot<\/strong> is a HSA registered medical device in Singapore.<\/p>\n

Regulations in other countries<\/h3>\n

For regulations of Axilum Robotics TMS-Cobot<\/b> outside the above regions, please contact Axilum Robotics<\/a>.<\/p>\n

 <\/p>\n

2- TMS-Robot<\/h2>\n

Regulations in the European Union<\/h3>\n

Axilum Robotics TMS-Robot<\/b> is manufactured by Axilum Robotics<\/a>. It is a device for medical or scientific investigation purposes, in order to automate the positioning of a Transcranial Magnetic Stimulation coil. Before any use, please read the user manual. Axilum Robotics TMS-Robot is not a CE marked medical device.<\/p>\n

Regulations in the USA<\/h3>\n

In the USA, federal law regulates the sale of Medical Devices through the US Food and Drug Administration (FDA). This is done to ensure safety and effectiveness. Devices which are permitted to be marketed for their intended use must either have a 510(k) or PMA clearance. Axilum Robotics TMS-Robot<\/b> is not FDA cleared. Please note that the use of Axilum Robotics TMS-Robot for the positionning of Transcranial Magnetic Stimulation (TMS, rTMS) coil is considered investigational in the USA. For further information please contact Axilum Robotics<\/a>.<\/p>\n

Regulations in other countries<\/h3>\n

For regulations of Axilum Robotics TMS-Robot<\/b> outside the European Union or the USA, please contact Axilum Robotics<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"

1- TMS-Cobot Regulations in the European Union Axilum Robotics TMS-Cobot is manufactured by Axilum Robotics. It is a Class IIa medical device intended to automate the positioning of a Transcranial Magnetic Stimulation coil. It holds the CE mark whose conformity has been assessed by Notified Body SGS 1639. Before any use, please read the user…<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_trash_the_other_posts":false,"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"editor_notices":[],"footnotes":""},"class_list":["post-168","page","type-page","status-publish","hentry"],"yoast_head":"\nRegulatory Information about Axilum Robotics TMS-Robot for Healthcare Professionals - Axilum Robotics [EN]<\/title>\n<meta name=\"description\" content=\"Regulatory information related to Axilum Robotics TMS-Robot in the European Union, Canada, the United States and the other countries\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.axilumrobotics.com\/en\/regulatory-information\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulatory Information about Axilum Robotics TMS-Robot for Healthcare Professionals - 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