FDA.reportPublic FDA data

ELECTROCORE, INC.

Matched from indexed company URL: Electrocore, LLC

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
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
00815203022687gammaCore Sapphire - gammaCore Sapphire Charging Station / Storage Case (Replacement with alternate power adapter)1-888-903-2673customerservice@electrocore.com
00815203022694gammaCore Emerald - gammaCore Emerald Charging Pad - Replacement1-888-903-2673customerservice@electrocore.com
00815203022700gammaCore Emerald - gammaCore Emerald Handset Assembly - Replacement1-888-903-2673customerservice@electrocore.com
00815203022717gammaCore Emerald - gammaCore Emerald Charging Cable - Replacement1-888-903-2673customerservice@electrocore.com
00815203022724gammaCore Emerald - gammaCore Emerald Charging Block - Replacement1-888-903-2673customerservice@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 - "gammaCore Sapphire, part number 10016-40303, 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. It can be programmed to deliver up to 30 doses per day for 93 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via a ""Refill Card"" encoded and provided by electroCore or its authorized agent. (Once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.) The Refill Card will be provided to the user / patient requesting a refill of their device, along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the ""refill"" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away. 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.

2018-04-06

gammaCore-2 - gammaCore-2 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. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). 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.

2018-04-06

gammaCore-2 - gammaCore-2 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. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). 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.

2018-04-06

gammaCore-2 - gammaCore-2 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. It can be programmed to deliver 24 doses per day for 31, 62, or 93 days (up to 99 days max). 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.

2018-04-06

gammaCore Refill Card 93-Day - "Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a ""gammaCore Refill Card"" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the ""refill"" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away."

electroCore, Inc.

2018-04-06

gammaCore Refill Card 31-Day - "Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a ""gammaCore Refill Card"" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the ""refill"" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away."

electroCore, Inc.

2018-04-06

gammaCore Refill Card 10-Day - "Based on the prescription from their HCP, GammaCore Sapphire users may request / receive a ""gammaCore Refill Card"" to refill the doses on their device. When requested, the Refill Card will be provided to the user / along with one to six additional tubes of conductive gel (number of tubes provided is based on the 10, 31, or 93 day refill being provided). On receipt of the Refill Card, the user refills the gammaCore device by placing the Card across the face of the device (with the device turned on). The device will display “rd” and the ""refill"" icon as the device reads the Card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device is now ready to be used for treatment. Each Refill Card can only be used for one refill; upon completion of the device refill the card may be thrown away."

electroCore, Inc.

2018-04-06

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