Nerivio
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Theranica Bio-Electronics LTD.
The following data is part of a premarket notification filed by Theranica Bio-electronics Ltd. with the FDA for Nerivio.
Pre-market Notification Details
| Device ID | K201824 |
| 510k Number | K201824 |
| Device Name: | Nerivio |
| Classification | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine |
| Applicant | Theranica Bio-Electronics LTD. 4 Ha-Omanut St. Netanya, IL 4250438 |
| Contact | Alon Ironi |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | QGT |
| CFR Regulation Number | 882.5899 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2020-10-23 |
Trademark Results [Nerivio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NERIVIO 79270961 not registered Live/Pending |
THERANICA BIO-ELECTRONICS LTD. 2019-08-06 |
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