Identity
- Trade Name
- Cervella FDA UDI
- Generic Name
- Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system FDA UDI
- Device Name
- Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz. FDA UDI
- Model / Reference
- Cervella CES FDA UDI
- Description
- Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz. FDA UDI
Identifiers
- Catalog Number
- Cervella FDA UDI
- Primary DI / UDI-DI
- 00860001493306 FDA UDI
- 510(k) Number
- K182311 FDA UDI
- FDA Product Code
- JXK FDA UDI
- GMDN Term
- Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Cervella by Innovative Neurological Devices, LLC — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Innovative Neurological Devices, LLC
Sources (1)
- FDA UDI 6e1bde1c-e2f3-44dc-892c-1e55648005ba 36 fields · synced May 30, 2026