Product code PKR

Device name

Non-Invasive Vagus Nerve Stimulator - Headache

Medical specialty

Neurology

Device class

2

Regulation number

882.5892

Review panel

NE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset