FDA.reportPublic FDA data

ELECTROCORE, INC.

Matched from indexed company URL: Electrocore, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155296033015529603ELECTROCORE, INC.1N2026-01-01200 Forge Way Suite 205 Rockaway NJ US 07866
30090609633009060963ELECTROCORE LLC1N2020-04-25150 Allen Rd Ste 201 Basking Ridge NJ US 07920

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00815203020089gammaCore Sapphire - gammaCore Sapphire SLC Handset, Replacement1-888-903-2673customerservice@electrocore.com
00815203021864gammaCore Sapphire - gammaCore Sapphire Charging Station / Storage Case - Replacement1-888-903-2673customerservice@electrocore.com
00815203022045gammaCore Sapphire - gammaCore Sapphire 31-Day Refill Card Only1-888-903-2673customerservice@electrocore.com
00815203022076gammaCore Sapphire - gammaCore Sapphire 12 Month Refill Card Only1-888-903-2673customerservice@electrocore.com
00815203022236gammaCore Sapphire - gammaCore Sapphire EVAL1-888-903-2673customerservice@electrocore.com
00815203022441gammaCore - Replacement Device Protective Cap, Clear1-888-903-2673customerservice@electrocore.com
00815203022458gammaCore - gammaCore Replacement Product Box Assembly, 5 Pack1-888-903-2673customerservice@electrocore.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2295751606382828K211856gammaCore SapphirePKR2021-09-10
2295751376246065K203546gammaCore SapphirePKR2021-02-12
2295751152707551K191830gammaCore SapphirePKR2020-03-26
2295751078445843K182369gammaCore SapphirePKR2018-11-27
2295751828636815K180538gammaCore SapphirePKR2018-03-30
2295751956747283K173442gammaCore-SPKR2018-01-23
2295751970109850K172270gammaCore-2PKR2017-12-07
1325981562171988K171306gammaCore-SPKR2017-05-30
2295751562171988K171306gammaCore-SPKR2017-05-30
1325981141336110DEN150048gammaCore Non-invasive Vagus Nerve StimulatorPKR2017-04-14
2295751141336110DEN150048gammaCore Non-invasive Vagus Nerve StimulatorPKR2017-04-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PKR112021-09-10

PMN#

GUDID#

gammaCore Sapphire D - gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40302 is programmed to deliver 24 doses per day for 6 months. Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

electroCore, Inc.

2020-05-22

gammaCore Sapphire D - gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40303 is programmed to deliver 24 doses per day for 12 months (1 year). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

electroCore, Inc.

2020-05-22

gammaCore Sapphire D - gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40304 is programmed to deliver 24 doses per day for 24 months (2 years). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

electroCore, Inc.

2020-05-22

gammaCore Sapphire D - gammaCore Sapphire D is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude. It includes a charging station incorporated into the “clam shell” storage case connected to a power adapter to charge the device as necessary by the end user. Catalog Number 11016-40305 is programmed to deliver 24 doses per day for 36 months (3 years). Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period. A manufacturer accessible only Bluetooth feature is enabled to facilitate device diagnostics of any devices returned to the manufacturer to allow a review of the number of days the device was used, number of doses provided, and any days / doses yet remaining on a device.

electroCore, Inc.

2020-05-22

gammaCore-S 250 - 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.

2020-05-22

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