The following data is part of a premarket notification filed by Cefaly Technology with the FDA for Cefaly Acute.
| Device ID | K171446 |
| 510k Number | K171446 |
| Device Name: | Cefaly Acute |
| Classification | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
| Applicant | CEFALY Technology Rue Louis Plescia 34 Seraing, BE 4102 |
| Contact | Jean-yves Mignolet |
| Correspondent | Jean-yves Mignolet CEFALY Technology Rue Louis Plescia 34 Seraing, BE 4102 |
| Product Code | PCC |
| CFR Regulation Number | 882.5891 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-16 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05425018850242 | K171446 | 000 |