Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015529603

FEI Number

3015529603

Entity Name

ELECTROCORE, INC.

City/State/Country

Rockaway, NJ, US

Establishment Address

200 Forge Way, Suite 205, Rockaway, NJ 07866, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

ElectroCore, Inc. (Owner Number: 10038007)

Owner / Operator Contact Address

200 Forge Way, Suite 205, Rockaway, NJ 07866, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203546

PMA Number

N/A

All Registered Proprietary Names

gammaCore Sapphire D gammaCore Sapphire 3 gammaCore Sapphire gammaCore Sapphire SLC gammaCore Sapphire gammaCore Sapphire 3 gammaCore-S gammaCore-S gammaCore-2 gammaCore Sapphire gammaCore gammaCore-S gammaCore Sapphire gammaCore-2 gammaCore Sapphire gammaCore Sapphire 3 gammaCore Sapphire SLC gammaCore Sapphire D gammaCore Emerald

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache	Neurology	Class 2	882.5892	2022-01-25
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2022-01-25
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2020-11-23
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache	Neurology	Class 2	882.5892	2020-11-23
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2017-06-28
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2017-06-28
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache	Neurology	Class 2	882.5892	2019-05-03
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2019-05-03
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2019-05-03
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2019-05-03
QAK	Non-Invasive Vagus Nerve Stimulator For Migraine Headache	Neurology	Class 2	882.5892	2022-01-25
PKR	Non-Invasive Vagus Nerve Stimulator - Headache	Neurology	Class 2	882.5892	2022-01-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ElectroCore, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015529603. Last updated year: 2026. Please use registration number 3015529603 when referencing this establishment in official correspondence.