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, Inc..
9
Total
8
Cleared
146d
Avg days
2017
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Non-invasive Vagus Nerve Stimulator - Headache Devices (Product Code PKR)
9 devices
Cleared
Sep 10, 2021
gammaCore Sapphire
Electrocore, Inc.
Neurology
86d
Cleared
Feb 12, 2021
gammaCore Sapphire
Electrocore, Inc.
Neurology
70d
About Product Code PKR - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PKR since 2017, with 8 receiving FDA clearance (average review time: 146 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
PKR devices are reviewed by the Neurology panel. Browse all Neurology devices →