Identity
- Trade Name
- Cefaly® FDA UDI
- Generic Name
- Craniofacial analgesia electrical stimulator FDA UDI
- Device Name
- The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults. FDA UDI
- Model / Reference
- Prevent FDA UDI
- Description
- The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults. FDA UDI
Identifiers
- Catalog Number
- 10230 FDA UDI
- Primary DI / UDI-DI
- 05425018850266 FDA UDI
- 510(k) Number
- K160237 FDA UDI
- FDA Product Code
- PCC FDA UDI
- GMDN Term
- Craniofacial analgesia electrical stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5891 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Craniofacial analgesia electrical stimulator
Cefaly® by Cefaly Technology SPRL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160237 also covers:
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
- Cefaly Technology SPRL
Sources (1)
- FDA UDI c64df6ad-231d-4f35-a861-483e1ea48e8d 37 fields · synced May 30, 2026