gammaCore-S 10009-40601

GUDID 00815203020010

gammaCore-Sis 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 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 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 300 2-minute treatments) over a 31-day period that commences the first time the unit is powered on and the stimulation intensity is raised to 5 or more.

ELECTROCORE, LLC

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• Primary Device ID: 00815203020010
• NIH Device Record Key: 5972866e-c727-4118-b8ba-573c13387f1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gammaCore-S
• Version Model Number: 10009-40601
• Catalog Number: 10009-40601
• Company DUNS: 831341628
• Company Name: ELECTROCORE, LLC
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 38 Degrees Celsius
• 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	00815203020010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171306

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: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-06-28

Devices Manufactured by ELECTROCORE, LLC

• 00815203020539 - gammaCore Sapphire SLC Device Kit: 2021-08-12 gammaCore Sapphire SLC 31-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea
• 00815203020546 - gammaCore Sapphire SLC Device Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day Device Kit is intended to provide nVNS stimulation on side of neck; it is indicated for acute trea
• 00815203020553 - gammaCore Sapphire SLC DEMO Device Kit: 2021-08-12 gammaCore Sapphire SLC 62-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati
• 00815203020560 - gammaCore Sapphire SLC DEMO Device Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day DEMO Device Kit is intended to be used to train HCPs and end users on proper use and the applicati
• 00815203020614 - gammaCore Sapphire SLC Refill Card Kit: 2021-08-12 gammaCore Sapphire SLC 31-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten
• 00815203020621 - gammaCore Sapphire SLC Refill Card Kit: 2021-08-12 gammaCore Sapphire SLC 93-Day Refill Card Kit intended for use with gammaCore Sapphire SLC Devices. gammaCore Sapphire is inten
• 00815203021260 - gammaCore Sapphire Device Starter Kit: 2021-08-12 gammaCore Sapphire 93-Day Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of neck
• 00815203021277 - gammaCore Sapphire Device Starter Kit: 2021-08-12 gammaCore Sapphire 6-Month Device Starter Kit (preprogrammed, refillable) is intended to provide nVNS stimulation on side of nec