Data / Medical devices / Belgium / Cefaly Technology
Cefaly Technology: FDA-registered device maker in Liege, Belgium, 7 510(k) clearances
Cefaly Technology is registered with the FDA (registration 3010188009) in Liege, Belgium. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated July 18, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010188009
- Address
- Legiapark Boulevard De Patience Et Beaujonc 3 Bte 28, Liege, Belgium, 4000
- Owner or operator
- CEFALY Technology (10046449)
- Roles
- Exporter to the US, Specification developer
- First device listed
- March 24, 2014
- Registered through
- 2027
- Brand names listed
- CEFALY, CEFALY Acute, CEFALY Connected, CEFALY Connected & CeCe Migraine Management App, CEFALY DUAL Enhanced, CEFALY Enhanced, CEFALY Prevent, Cefaly and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 18, 2024 | K234029 | CEFALY Connected - OTC, CEFALY Connected - Rx | PCC | Substantially Equivalent | Cefaly Technology | accessdata.fda.gov |
| December 13, 2022 | K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | PCC | Substantially Equivalent | Cefaly Technology | accessdata.fda.gov |
| September 29, 2020 | K201895 | Cefaly Dual | PCC | Substantially Equivalent | Cefaly Technology | accessdata.fda.gov |
| November 28, 2017 | K173006 | Cefaly Dual | PCC | Substantially Equivalent | Cefaly Technology | accessdata.fda.gov |
| September 15, 2017 | K171446 | Cefaly Acute | PCC | Substantially Equivalent | Cefaly Technology | accessdata.fda.gov |
| March 4, 2016 | K160237 | Cefaly | PCC | Substantially Equivalent | Cefaly Technology | accessdata.fda.gov |
| March 11, 2014 | DEN120019 | CEFALY | PCC | Unknown | Stx-Med Sprl | accessdata.fda.gov |
Compare with other makers
Updated July 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.