PKR
9 FDA 510(k) clearances · Product code
86 daysmedian time to decision
546 days90th percentile
9clearances measured
FDA profile
- Official device name
- Non-Invasive Vagus Nerve Stimulator - Headache
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5892
- Medical specialty
- Neurology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| gammaCore Sapphire (K211856) | Electrocore, Inc. | 2021-09-10 |
| gammaCore Sapphire (K203546) | Electrocore, Inc. | 2021-02-12 |
| gammaCore Sapphire (K191830) | Electrocore, Inc. | 2020-03-26 |
| gammaCore Sapphire (K182369) | Electrocore, Inc. | 2018-11-27 |
| gammaCore Sapphire (K180538) | Electrocore, LLC | 2018-03-30 |
| gammaCore-S (K173442) | Electrocore, LLC | 2018-01-23 |
| gammaCore-2 (K172270) | Eletrocore, LLC | 2017-12-07 |
| gammaCore-S (K171306) | Electrocore, LLC | 2017-05-30 |
| gammaCore Non-invasive Vagus Nerve Stimulator (DEN150048) | Electrocore, LLC | 2017-04-14 |
Track PKR automatically
Every clearance here is in the API, with alerts when new ones post.