MindMotion GO Procedure Pack

Description

The MindMotion GO Procedure Pack is a combination of CE-marked and FDA-listed medical devices and compatible non-medical components packaged together and placed on the market by NeuroXtherapeutics SA in accordance with Article 22 of Regulation (EU) 2017/745. In the US, a procedure pack is commonly referred to as a “convenience kit”, defined as "two or more different medical devices packaged together for the convenience of the user" 21 CFR 801.3. Convenience kits are considered medical devices in their own right and must be listed under the primary intended use of the kit, using the most appropriate product code. The risk classification of the kit is determined by the highest risk component included. Therefore, MindMotion GO Procedure Pack is considered as a convenience kit in the US, but in all documentation it will be referred to it as 'Procedure Pack'. The Procedure Pack is assembled to enable the use of the medical devices MindMotion GO and Izar for their intended medical purposes. It provides healthcare professionals with the necessary components required for installation and operation of the devices in clinical settings or at a patient’s home under professional supervision. The Procedure Pack does not create a new medical intended purpose and does not modify the intended purpose, performance, or classification of the individual medical devices included therein.