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 manual.
Download Axilum Robotics TMS-Cobot CE marking certificate.
Regulations in the USA
Axilum Robotics TMS-Cobot has 510(k) clearance from the FDA (Food and Drug Administration) in the USA (FDA clearance K182768 Class II). Axilum Robotics TMS-Cobot® TS MV is indicated for the spatial positioning and orientation of the treatment coil of the MagVenture TMS Therapy system.
Regulations in Australia
Axilum Robotics TMS-Cobot 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.
Regulations in Singapore
Axilum Robotics TMS-Cobot is a HSA registered medical device in Singapore.
Regulations in other countries
For regulations of Axilum Robotics TMS-Cobot outside the above regions, please contact Axilum Robotics.
2- TMS-Robot
Regulations in the European Union
Axilum Robotics TMS-Robot is manufactured by Axilum Robotics. 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.
Regulations in the USA
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 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.
Regulations in other countries
For regulations of Axilum Robotics TMS-Robot outside the European Union or the USA, please contact Axilum Robotics.