PKR — Non-Invasive Vagus Nerve Stimulator - Headache Class II
FDA product code PKR covers "Non-Invasive Vagus Nerve Stimulator - Headache", a Class II medical device regulated under 21 CFR 882.5892. Submissions are reviewed by the Neurology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PKR
- Device Class
- Class II
- Regulation Number
- 882.5892
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
The device intended for non-invasive vagus nerve stimulation (nVNS) on the side of the neck to treat cluster headache and to reduce the frequency of cluster headache attacks.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K211856 | electrocore | gammaCore Sapphire | September 10, 2021 |
| K203546 | electrocore | gammaCore Sapphire | February 12, 2021 |
| K191830 | electrocore | gammaCore Sapphire | March 26, 2020 |
| K182369 | electrocore | gammaCore Sapphire | November 27, 2018 |
| K180538 | electrocore | gammaCore Sapphire | March 30, 2018 |
| K173442 | electrocore | gammaCore-S | January 23, 2018 |
| K172270 | eletrocore | gammaCore-2 | December 7, 2017 |
| K171306 | electrocore | gammaCore-S | May 30, 2017 |
| DEN150048 | electrocore | gammaCore Non-invasive Vagus Nerve Stimulator | April 14, 2017 |