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Cefaly Dual Enhanced with RFID

by Cefaly Technology

510(k) K212071

Active European Union and United States

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) K212071↗

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 NumberK212071 Date13 Dec 2022ClearedStatusActive
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  • Withdrawn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/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
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 Dual Enhanced with RFID is a Transcutaneous Electrical Nerve Stimulator (TENS) designed for migraine relief. Classified as a nerve stimulator under the OpenFDA nomenclature, it delivers controlled electrical impulses to targeted nerve pathways to alleviate migraine symptoms. This device is intended for over-the-counter (OTC) and prescription (Rx) use, offering dual-channel stimulation capabilities with RFID connectivity for enhanced tracking and functionality.

Supplied as a reusable medical device, the Cefaly Dual Enhanced with RFID is intended for home or clinical use under the guidance of a healthcare professional. It adheres to FDA 510(k) clearance and MDD (Medical Device Directive) requirements, ensuring compliance with regulatory standards. The device is non-sterile and requires proper storage as specified by the manufacturer. No MRI safety information is provided in the specifications.

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 primary purpose of the Cefaly Dual Enhanced with RFID device, and how does it differ from other TENS units for migraine relief?

    The Cefaly Dual Enhanced with RFID is specifically designed as a Transcutaneous Electrical Nerve Stimulator (TENS) for migraine relief, delivering controlled electrical impulses to targeted nerve pathways. Unlike standard TENS units, it offers dual-channel stimulation, allowing simultaneous treatment of multiple nerve pathways, and includes RFID connectivity for enhanced tracking and functionality. This dual-channel capability and connectivity set it apart from basic TENS devices, making it a more advanced option for migraine management.

  • Is the Cefaly Dual device reusable, and if so, what storage instructions should be followed to maintain its functionality?

    Yes, the Cefaly Dual Enhanced with RFID and Cefaly Dual Connected are reusable medical devices intended for use in both home and clinical settings. Since they are non-sterile, proper storage is critical to prevent contamination and ensure longevity. The manufacturer specifies storage guidelines, though exact details (e.g., temperature, humidity, or protection from moisture) are not provided in the data. Always follow the manufacturer’s instructions to maintain device integrity and performance.

  • Are these devices available over-the-counter (OTC) or only by prescription, and what regulatory pathways have they undergone?

    The Cefaly Dual Enhanced with RFID and Cefaly Dual Connected are available both over-the-counter (OTC) and by prescription (Rx), catering to different patient access needs. Regulatory compliance includes FDA 510(k) clearance (determined as *Substantially Equivalent* under the Neurology advisory committee) and adherence to the EU Medical Device Directive (MDD). These pathways confirm the devices meet safety and performance standards for their intended use.

  • What safety considerations should clinicians or users be aware of regarding MRI compatibility with these devices?

    The provided specifications do not include any MRI safety information for the Cefaly Dual Enhanced with RFID or Cefaly Dual Connected devices. This means users should assume the devices may not be MRI-safe unless explicitly confirmed by the manufacturer. Patients or clinicians should consult the manufacturer’s guidelines or contact them directly before using the device in an MRI environment to avoid potential risks.