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64000-00120 Rev 3
1. INTENDED USE AND PRODUCT DESCRIPTION
gammaCore-S (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus
nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for the acute treatment of
pain associated with episodic cluster headache and migraine headache in adult patients.
FDA review is based on a clinical comparison of probable risks and benefits to health and FDA has
determined probable benefit to health based on clinical evidence submitted to FDA and patient
preference information.
gammaCore provides a mild electrical stimulation of the vagus nerve, which runs through the neck
and carries information to the central nervous system. Each stimulation with gammaCore lasts two
minutes (120 seconds). The patient controls the stimulation intensity. After the first time gammaCore is
powered on, the device will operate for 31 consecutive days.
gammaCore is supplied non-sterile.
The safety and effectiveness of this device is based on a comparison of its low risks and
probable benefit to health. The FDA has determined probable benefit to health based
on the patient’s stated preference for the device.
For prescription use only.
2. WHAT SHOULD I EXPECT?
People respond differently to nVNS.
Acute treatment of episodic cluster headache
Based on the clinical trials conducted with gammaCore, and unless otherwise directed by your
healthcare provider (HCP), each self-administered treatment should consist of three 2-minute
stimulations applied consecutively at the onset of cluster headache pain or symptoms.
If the cluster headache attack is not aborted, you may administer an additional treatment, consisting
of three consecutive 2-minute stimulations, three minutes after the first treatment. Treatments may be
applied to either side of the neck.
Device Feature
Description / Use
Stimulation Surfaces Points of contact with
patient’s skin
Light
Indicates device status
(refer to Section 7)
Display
Indicates device status
(refer to Section 7)
Control buttons
Turn power ON/OFF
INCREASE/DECREASE
stimulation intensity
Caps
Cover and protect the
stimulation surfaces
