Modius Calm is a non-invasive, home-use neurostimulation device that is indicated to treat Generalized Anxiety Disorder (GAD) in adults. The device utilizes a technology known as electrical…
Modius Calm is a non-invasive, home-use neurostimulation device that is indicated to treat Generalized Anxiety Disorder (GAD) in adults. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS). It consists of a battery-powered device designed to deliver low-level electrical energy to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads that placed on the skin behind each ear.
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Modius Calm | Listed by | Neurovalens, United Kingdom |
| FDA product code | QJQ |
| Device type | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5800 |
| Establishment | Specification developer, Private-label distributor, Manufacturer |
| 510(k) | K232253 |
| Record published | 2025-04-04 |
Specifications
Specifications | MRI safety | MR Unsafe |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.