gammaCore-S 250 11009-40001

GUDID 00815203020485

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.

electroCore, Inc.

Migraine-therapy peripheral nerve electrical stimulator

• Primary Device ID: 00815203020485
• NIH Device Record Key: ce6dd637-89f6-46e8-b896-7e37205b7481
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore-S 250
• Version Model Number: 11009-40001
• Catalog Number: 11009-40001
• Company DUNS: 831341628
• Company Name: electroCore, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com
• Phone: 1-888-903-2673
• Email: customerservice@electrocorellc.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Atmospheric Pressure: Between 0 KiloPascal and 80 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815203020485 [Primary]

FDA Product Code

• PKR: Non-Invasive Vagus Nerve Stimulator - Headache

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-12-18
• Device Publish Date: 2020-05-22

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