# Non-Invasive Vagus Nerve Stimulator - Headache
> **Product code: PKR** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5892
## Classification
- **FDA Product Code:** PKR
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.5892
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 9
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PKR)
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