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CEFALY Connected - OTC, CEFALY Connected - Rx

by Cefaly Technology

510(k) K234029

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K234029↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK234029 Date18 Jul 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
PCC
Device Class
Class II
Regulation
21 CFR Part 882.5891
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cefaly Connected is classified as an Electrical, Transcutaneous, Nerve Stimulator for Migraine, designed to deliver non-invasive electrical stimulation to the trigeminal nerve via the forehead to alleviate migraine symptoms. This device operates as a portable, wearable stimulator intended for self-administration by patients, providing targeted nerve modulation to help prevent or reduce migraine attacks.

The Cefaly Connected is supplied as a reusable device, intended for home use with no requirement for sterilisation. It is authorised under FDA 510K clearance, MDD, and MDR compliance, with regulatory classification as a Class II medical device. The system includes a handheld stimulator unit and adhesive electrodes, requiring no special storage conditions beyond a dry environment. Multiple registration numbers (e.g., 3015946733) and FEI numbers confirm its regulatory filing and approval status.

Other devices from Cefaly Technology

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CEFALY Connected device used for?

    The CEFALY Connected is an electrical, transcutaneous nerve stimulator designed to deliver non-invasive electrical stimulation to the trigeminal nerve via the forehead to help prevent or reduce migraine symptoms.

  • How is the CEFALY Connected device supplied?

    The device is supplied as a reusable system that includes a handheld stimulator unit and adhesive electrodes, intended for home use with no requirement for sterilisation.

  • What are the storage requirements for the CEFALY Connected device?

    The device requires no special storage conditions beyond being kept in a dry environment, making it convenient for home use.

  • Is the CEFALY Connected device single-use or reusable?

    The CEFALY Connected is a reusable device designed for multiple applications, eliminating the need for frequent replacement.

  • What is the regulatory classification of the CEFALY Connected device?

    The device is classified as a Class II medical device with FDA 510K clearance, MDD, and MDR compliance, indicating it meets specific safety and effectiveness standards.