Device class
Class II
Regulation 882.5892
Total clearances
3
2020-03-26 → 2021-09-10
Definition
What is Non-Invasive Vagus Nerve Stimulator - Headache
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.
Classification details
Medical specialty
Neurology
Regulation number
882.5892
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 64568 |
CPT
|
— |
High
|
Vagus nerve stimulation (VNS) pulse generator implantation or revision applicable |
| 64569 |
CPT
|
— |
Medium
|
Vagus nerve stimulation electrode implantation (non-invasive device related) |
Pulse
Most recent 510(k) clearances