Regulations in the European Union
Axilum Robotics TMS-Robot 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 0120. Before any use, please read the user manual.
Regulations in Canada
Axilum Robotics TMS-Robot is manufactured by Axilum Robotics. It is a Class II medical device intended to automate the positioning of a Transcranial Magnetic Stimulation coil. It holds Medical Device Licence number 92610 issued by Health Canada according to the Canadian Medical Device Regulations, Section 36. Before any use, please read the user manual.
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, Canada or the USA, please contact Axilum Robotics.
TMS-Cobot is a Class IIa medical device whose CE marking is under evaluation by CE 0120 SGS notified body