Identity
- Trade Name
- Modius Sleep FDA UDI
- Generic Name
- Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system FDA UDI
- Device Name
- Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia 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. FDA UDI
- Model / Reference
- MS1000 FDA UDI
- Description
- Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat chronic insomnia 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05070002841203 FDA UDI
- 510(k) Number
- K230826 FDA UDI
- FDA Product Code
- QJQ FDA UDI
- GMDN Term
- Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Modius Sleep by Neurovalens Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neurovalens Limited
Sources (1)
- FDA UDI 884a5d2e-0b46-49e3-be62-e5c1d80a4a74 34 fields · synced May 30, 2026