1- TMS-Robot

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.

 

CE 0120

icone_pdf Download Axilum Robotics TMS-Robot CE marking certificate.

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.

2- 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 0120. Before any use, please read the user manual.

 

CE 0120icone_pdf 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.

Regulations in other countries

For regulations of Axilum Robotics TMS-Cobot outside the European Union or the USA, please contact Axilum Robotics.