Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010188009

FEI Number

3010188009

Entity Name

CEFALY TECHNOLOGY

City/State/Country

Liege, BE

Establishment Address

Boulevard Patience et Beaujonc 3, bte 28, Liege 4000, BE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

CEFALY Technology (Owner Number: 10046449)

Owner / Operator Contact Address

Boulevard Patience et Beaujonc 3, bte 28, Liege, BE-WLG 4000, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212071

PMA Number

N/A

All Registered Proprietary Names

Cefaly Dual CEFALY DUAL Enhanced Cefaly Dual CEFALY Acute Cefaly CEFALY Connected & CeCe Migraine Management App CEFALY Connected CEFALY Enhanced

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2020-10-12
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2017-11-29
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2017-09-27
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2014-03-24
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2024-07-30
PCC	Stimulator, Nerve, Electrical, Transcutaneous, For Migraine	Neurology	Class 2	882.5891	2022-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Andy Page Business: CEFALY US Email: regulatory@cefaly.com Phone: (650) 9062334

Related Public Records

Same Entity

CEFALY Technology

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010188009. Last updated year: 2026. Please use registration number 3010188009 when referencing this establishment in official correspondence.