Identifiers
- 510(k) Number
- K232253 FDA 510(k)
- FDA Product Code
- QJQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5800 FDA 510(k)
- Regulation Number
- 882.5800 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Modius Stress is a Cranial Electrotherapy Stimulator (CES) designed to deliver low-intensity electrical currents to the brain via electrodes placed on the head. It is classified under 21 CFR 882.5800 and intended for use in treating symptoms associated with generalised anxiety disorder (GAD). The device operates by modulating neural activity to promote relaxation and reduce stress responses.
This Class II medical device is supplied as a reusable system with disposable electrode pads for single-use applications. It is not MRI-safe and requires proper storage in a dry, temperature-controlled environment to maintain functionality. Authorised under FDA 510(k) clearance (K232253), the Modius Stress adheres to regulatory standards for cranial electrotherapy stimulators, ensuring compliance with 21 CFR 882.5800 and Product Code QJQ for neurology applications.
Frequently asked questions
What is the Modius Stress designed to help manage, and how does it work?
The Modius Stress is a Cranial Electrotherapy Stimulator (CES) intended for managing symptoms associated with generalized anxiety disorder (GAD). It delivers low-intensity electrical currents to the brain via electrodes placed on the head, modulating neural activity to promote relaxation and reduce stress responses. This non-invasive approach targets the brain’s electrical activity to help alleviate anxiety symptoms.
Is the Modius Stress reusable, and what about the electrode pads? How should they be stored?
The Modius Stress device itself is a reusable system, but it comes with disposable electrode pads designed for single-use applications. To maintain functionality, the reusable device must be stored in a dry, temperature-controlled environment—avoiding moisture or extreme temperatures that could compromise its performance.
Can the Modius Stress be used in an MRI environment, and what safety precautions should be taken?
The Modius Stress is not MRI-safe, meaning it should never be used or stored near MRI machines. Since it contains electronic components, exposure to MRI fields could cause malfunctions or pose safety risks. Always follow facility protocols for non-MRI-compatible devices.
What regulatory pathway was followed for the Modius Stress, and what does that mean for its use?
The Modius Stress received FDA 510(k) clearance (K232253) under the Traditional Review pathway, demonstrating it is substantially equivalent to legally marketed predecessors. This clearance confirms compliance with 21 CFR 882.5800 for cranial electrotherapy stimulators and ensures it meets safety and effectiveness standards for treating anxiety-related symptoms as specified in its intended use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Modius Calm - The Wearable Anxiety Relief Device You Need, FDA clears Neurovalens' Modius Stress device to treat anxiety, PDF Jason Mckeown, MD CEO 8 Carmagrim Road Ballymena, County Antrim BT44 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232253 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurovalens Limited
Sources (1)
- FDA 510(k) K232253 24 fields · synced Sep 18, 2026