Data / Medical devices / United States / Electrocore, Inc.
Electrocore, Inc.: FDA-registered device maker in Rockaway, NJ, United States, 9 510(k) clearances
Electrocore, Inc. is registered with the FDA (registration 3015529603) in Rockaway, NJ, United States. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated September 10, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015529603
- Address
- 200 Forge Way Suite 205, Rockaway, NJ, United States, 07866
- Owner or operator
- ElectroCore, Inc. (10038007)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 28, 2017
- Registered through
- 2026
- Brand names listed
- gammaCore, gammaCore Emerald, gammaCore Sapphire, gammaCore Sapphire 3, gammaCore Sapphire D, gammaCore Sapphire SLC, gammaCore-2, gammaCore-S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Non-Invasive Vagus Nerve Stimulator - Headache | PKR | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Non-Invasive Vagus Nerve Stimulator For Migraine Headache | QAK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 10, 2021 | K211856 | gammaCore Sapphire | PKR | Substantially Equivalent | Electrocore, Inc. | accessdata.fda.gov |
| February 12, 2021 | K203546 | gammaCore Sapphire | PKR | Substantially Equivalent | Electrocore, Inc. | accessdata.fda.gov |
| March 26, 2020 | K191830 | gammaCore Sapphire | PKR | Substantially Equivalent | Electrocore, Inc. | accessdata.fda.gov |
| November 27, 2018 | K182369 | gammaCore Sapphire | PKR | Substantially Equivalent | Electrocore, Inc. | accessdata.fda.gov |
| March 30, 2018 | K180538 | gammaCore Sapphire | PKR | Substantially Equivalent | Electrocore, LLC | accessdata.fda.gov |
| January 23, 2018 | K173442 | gammaCore-S | PKR | Substantially Equivalent | Electrocore, LLC | accessdata.fda.gov |
| December 7, 2017 | K172270 | gammaCore-2 | PKR | Substantially Equivalent | Eletrocore, LLC | accessdata.fda.gov |
| May 30, 2017 | K171306 | gammaCore-S | PKR | Substantially Equivalent | Electrocore, LLC | accessdata.fda.gov |
| April 14, 2017 | DEN150048 | gammaCore Non-invasive Vagus Nerve Stimulator | PKR | Unknown | Electrocore, LLC | accessdata.fda.gov |
Updated September 10, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.