PKR · Class II · 21 CFR 882.5892

FDA Product Code PKR: Non-invasive Vagus Nerve Stimulator - Headache

The Device Intended For Non-invasive Vagus Nerve Stimulation (nvns) On The Side Of The Neck To Treat Cluster Headache And To Reduce The Frequency Of Cluster Headache Attacks.

Leading manufacturers include Electrocore, LLC, Electrocore, Inc. and Eletrocore, LLC.

9
Total
8
Cleared
146d
Avg days
2017
Since

FDA 510(k) Cleared Non-invasive Vagus Nerve Stimulator - Headache Devices (Product Code PKR)

9 devices
1–9 of 9
Cleared Sep 10, 2021
gammaCore Sapphire
K211856
Electrocore, Inc.
Neurology · 86d
Cleared Feb 12, 2021
gammaCore Sapphire
K203546
Electrocore, Inc.
Neurology · 70d
Cleared Mar 26, 2020
gammaCore Sapphire
K191830
Electrocore, Inc.
Neurology · 261d
Cleared Nov 27, 2018
gammaCore Sapphire
K182369
Electrocore, Inc.
Neurology · 88d
Cleared Mar 30, 2018
gammaCore Sapphire
K180538
Electrocore, LLC
Neurology · 30d
Cleared Jan 23, 2018
gammaCore-S
K173442
Electrocore, LLC
Neurology · 78d
Cleared Dec 07, 2017
gammaCore-2
K172270
Eletrocore, LLC
Neurology · 132d
Cleared May 30, 2017
gammaCore-S
K171306
Electrocore, LLC
Neurology · 27d
Not Cleared Apr 14, 2017
gammaCore Non-invasive Vagus Nerve Stimulator
DEN150048
Electrocore, LLC
Neurology · 546d

About Product Code PKR - Regulatory Context