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Cefaly Acute Stimulator, Nerve, Electrical, Transcutaneous

by Cefaly Technology

510(k) K171446

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) K171446↗

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 NumberK171446 Date15 Sep 2017ClearedStatusActive
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  • Withdrawn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)

Full name
Cefaly Acute
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 Acute is a transcutaneous electrical nerve stimulator (TENS) designed for migraine relief. Classified as a nerve stimulator, it delivers controlled electrical impulses to the trigeminal nerve via a wearable device applied to the forehead, targeting acute migraine pain.

This device is supplied as a non-invasive, reusable system intended for home use. It operates without MRI compatibility restrictions and is authorised under FDA 510(k) clearance, MDD, and MDR. The product includes multiple electrode configurations (registration numbers 3015946733–3005170249) and is regulated under device class 2 (PCC product code). Storage and handling follow standard electrical medical device guidelines.

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 Acute designed to treat, and how does it work?

    The Cefaly Acute is a transcutaneous electrical nerve stimulator (TENS) specifically designed for acute migraine relief. It delivers controlled electrical impulses to the trigeminal nerve via electrodes placed on the forehead, helping to interrupt migraine pain signals. It is non-invasive and intended for home use, offering a wearable solution for managing migraine attacks.

  • Is the Cefaly Acute reusable, or is it meant for single-use?

    The Cefaly Acute is explicitly described as a reusable system, meaning it is designed for repeated use by the same patient. This makes it cost-effective for long-term migraine management at home, as it does not require disposal after each use.

  • What types of electrode configurations are included with the Cefaly Acute?

    The device includes multiple electrode configurations, each with a unique registration number (e.g., 3015946733–3005170249). These variations allow flexibility in placement and application to target migraine relief effectively, though the exact configurations are not detailed beyond their existence.

  • How should the Cefaly Acute be stored, and are there any special handling instructions?

    As a reusable electrical medical device, the Cefaly Acute should be stored and handled according to standard electrical medical device guidelines. This typically includes keeping it in a dry, clean environment, away from extreme temperatures or moisture, and following manufacturer instructions for maintenance to ensure safety and functionality.

  • What regulatory pathways has the Cefaly Acute followed, and how does this affect its use?

    The Cefaly Acute has undergone FDA 510(k) clearance, as well as authorization under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means it has been evaluated for safety and effectiveness by regulatory bodies, ensuring it meets established standards for nerve stimulators. Clinicians and users can rely on its compliance with these frameworks for clinical and home use.