The following data is part of a premarket notification filed by Theranica Bioelectronics Ltd with the FDA for Nerivio, Fgd000075-4.7.
| Device ID | K203181 |
| 510k Number | K203181 |
| Device Name: | Nerivio, FGD000075-4.7 |
| Classification | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine |
| Applicant | Theranica Bioelectronics Ltd 4 Ha-Omanutst. Poleg Industrial Park Netanya, IL 4250574 |
| Contact | Alon Ironi |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street Suite 2300 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 | 2020-10-26 |
| Decision Date | 2021-01-22 |