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.
| Device Type ID | 3787 |
| Device Name | Non-invasive Vagus Nerve Stimulator - Headache |
| Physical State | The Device Is A Hand-held Portable Device Consisting Of An Outer Plastic Case, A Battery, Signal Generating And Amplifying Electronics, A Control To Power On The Device And Control Stimulation Intensity, And A Pair Of Stainless Steel Skin Contact Sur |
| Technical Method | The Device Produces A Low Voltage Electric Signal That Generates An Electric Field In The Vicinity Of The Vagus Nerve. The Strength Of The Stimulation Is Lower Than That Required To Activate Efferent Vagus Nerve Stimulation That Mediates Cardiac Spec |
| Target Area | The Device Is Used On The Side Of The Neck For Non-invasive Vagus Nerve Stimulation (nVNS). |
| Regulation Description | External Vagal Nerve Stimulator For Headache. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5892 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PKR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3787 |
| Device | Non-invasive Vagus Nerve Stimulator - Headache |
| Product Code | PKR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | External Vagal Nerve Stimulator For Headache. |
| CFR Regulation Number | 882.5892 [🔎] |