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gammaCore-S 250

FDA UDI

Class II (US FDA UDI)

by ElectroCore, Inc.

Identity

Trade Name
gammaCore-S 250 FDA UDI
Generic Name
Migraine-therapy peripheral nerve electrical stimulator FDA UDI
Device Name
gammaCore-S 250 is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (to indicate device status), and a pair of stainless-steel skin contact or stimulation surfaces. gammaCore-S 250 uses two buttons to power on the device and for operator control of the signal amplitude / stimulation intensity. The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device. The gammaCore-S 250 device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 250 2-minute treatments) over its service life (gammaCore-S 250 service life is defined as 250 treatments or when the on-board batteries are fully discharged) that commences the first time the unit is powered on and the stimulation intensity is raised to 5 or more. FDA UDI
Model / Reference
11009-40001 FDA UDI
Description
gammaCore-S 250 is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (to indicate device status), and a pair of stainless-steel skin contact or stimulation surfaces. gammaCore-S 250 uses two buttons to power on the device and for operator control of the signal amplitude / stimulation intensity. The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device. The gammaCore-S 250 device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 250 2-minute treatments) over its service life (gammaCore-S 250 service life is defined as 250 treatments or when the on-board batteries are fully discharged) that commences the first time the unit is powered on and the stimulation intensity is raised to 5 or more. FDA UDI

Identifiers

Catalog Number
11009-40001 FDA UDI
Primary DI / UDI-DI
00815203020485 FDA UDI
FDA Product Code
PKR FDA UDI
QAK FDA UDI
GMDN Term
Migraine-therapy peripheral nerve electrical stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5892 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Migraine-therapy peripheral nerve electrical stimulator

gammaCore-S 250 by ElectroCore, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Migraine-therapy peripheral nerve electrical stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ElectroCore, Inc.

Sources (1)

  • FDA UDI ce6dd637-89f6-46e8-b896-7e37205b7481 36 fields · synced May 30, 2026