The following data is part of a premarket notification filed by Cefaly Technology with the FDA for Cefaly.
| Device ID | K160237 |
| 510k Number | K160237 |
| Device Name: | Cefaly |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | CEFALY TECHNOLOGY ZI DES HAUTS SARTS, 4EME AVENUE 5 Herstal, BE 4040 |
| Contact | Jean-yves Mignolet |
| Correspondent | Jean-yves Mignolet CEFALY TECHNOLOGY ZI DES HAUTS SARTS, 4EME AVENUE 5 Herstal, BE 4040 |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05425018850129 | K160237 | 000 |
| 05425018850150 | K160237 | 000 |
| 05425018850143 | K160237 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CEFALY 87924056 not registered Live/Pending |
CEFALY Technology 2018-05-16 |
![]() CEFALY 79053734 3647710 Live/Registered |
CEFALY Technology 2008-04-28 |