Cefaly

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

CEFALY TECHNOLOGY

The following data is part of a premarket notification filed by Cefaly Technology with the FDA for Cefaly.

Pre-market Notification Details

Device IDK160237
510k NumberK160237
Device Name:Cefaly
ClassificationStimulator, Nerve, Electrical, Transcutaneous, For Migraine
Applicant CEFALY TECHNOLOGY ZI DES HAUTS SARTS, 4EME AVENUE 5 Herstal,  BE 4040
ContactJean-yves Mignolet
CorrespondentJean-yves Mignolet
CEFALY TECHNOLOGY ZI DES HAUTS SARTS, 4EME AVENUE 5 Herstal,  BE 4040
Product CodePCC  
CFR Regulation Number882.5891 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-01
Decision Date2016-03-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05425018850129 K160237 000
05425018850150 K160237 000
05425018850143 K160237 000

Trademark Results [Cefaly]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CEFALY
CEFALY
87924056 not registered Live/Pending
CEFALY Technology
2018-05-16
CEFALY
CEFALY
79053734 3647710 Live/Registered
CEFALY Technology
2008-04-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.