gammaCore-S 250
Basic Information
- Brand Name
- gammaCore-S 250
- Primary DI
- 00815203020485
- Version / Model
- 11009-40001
- Catalog Number
- 11009-40001
- Company Name
- ELECTROCORE, LLC
- Labeler DUNS
- 831341628
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-22
- Public Version
- 1
- Public Version Date
- 2020-06-01
- Public Version Status
- New
- Public Device Record Key
- ce6dd637-89f6-46e8-b896-7e37205b7481
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | Neurology | 882.5892 | 2 |
| QAK | Non-Invasive Vagus Nerve Stimulator For Migraine Headache | Neurology | 882.5892 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58832 | Migraine-therapy peripheral nerve electrical stimulator | A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls, user display, and metal skin contact surfaces that enable application of the electrical signal intended to provide a localized oscillating electric field; it may be used in conjunction with a smartphone. The device is typically used with conductive gel and may be operated by a patient or healthcare provider in the home and healthcare facility. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815203020485 | GS1 |
Customer Contacts
- Phone
- 1-888-903-2673
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Replace caps after each use; store device so caps remain in place and are not inadvertantly removed.
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- – 80 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- – 80 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius