Non-Invasive Vagus Nerve Stimulator - Headache
The Non-Invasive Vagus Nerve Stimulator - Headache (product code PKR) is a Class 2 neurology device intended for non-invasive vagus nerve stimulation (nVNS) applied to the side of the neck to treat cluster headache and reduce the frequency of cluster headache attacks, regulated under 882.5892. It requires 510(k) clearance and is not an implant or life-sustaining device. The device represents a non-invasive neuromodulation approach to headache management.
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Basic Information
- Product Code
- PKR
- Device Class
- FDA class 2
- Regulation Number
- 882.5892
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K211856 | gammaCore Sapphire | Sep 10, 2021 | Substantially Equivalent | Electrocore, Inc. |
| K203546 | gammaCore Sapphire | Feb 12, 2021 | Substantially Equivalent | Electrocore, Inc. |
| K191830 | gammaCore Sapphire | Mar 26, 2020 | Substantially Equivalent | Electrocore, Inc. |
| K182369 | gammaCore Sapphire | Nov 27, 2018 | Substantially Equivalent | Electrocore, Inc. |
| K180538 | gammaCore Sapphire | Mar 30, 2018 | Substantially Equivalent | Electrocore, LLC |
| K173442 | gammaCore-S | Jan 23, 2018 | Substantially Equivalent | Electrocore, LLC |
| K172270 | gammaCore-2 | Dec 07, 2017 | Substantially Equivalent | Eletrocore, LLC |
| K171306 | gammaCore-S | May 30, 2017 | Substantially Equivalent | Electrocore, LLC |
| DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | Apr 14, 2017 | Unknown | Electrocore, LLC |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.