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Non-Invasive Vagus Nerve Stimulator - Headache

FDA product code PKR · 8 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.5892
Review panel
NE
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-05-30 – 2021-09-10

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.

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