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MindMotion GO Procedure Pack

NeuroXtherapeutics SA · Model MMG-02-PC3-AAA-01-US · UDI-DI 03760272650774

QKC Prescription

510(k) clearances

Adverse events

Recalls

Facilities

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 as convenience kit. 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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.