Identifiers
- 510(k) Number
- K171306 FDA 510(k)
- FDA Product Code
- PKR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5892 FDA 510(k)
- Regulation Number
- 882.5892 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The gammaCore-S is a Non-Invasive Vagus Nerve Stimulator - Headache device. It is substantially equivalent to a predicate device and has been reviewed by the Neurology advisory committee.
The device is supplied by Electrocore, LLC and operates with a low voltage electric signal consisting of five 5000 Hz pulses repeated at 25 Hz, producing a sine wave waveform with a peak voltage limited to 24 Volts on the skin and a maximum output current of 60mA. It is authorized under FDA 510(k) clearance K171306 and is classified as a Class II medical device under regulation number 882.5892.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K173442 FDA 510 (k) - gammaCore-S | Electrocore, LLC, ELECTROCORE, LLC - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171306 | Class II | Active |
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Manufacturer
- Manufacturer
- Electrocore, Llc
Sources (1)
- FDA 510(k) K171306 24 fields · synced Sep 22, 2026