510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PKRClass II

Non-Invasive Vagus Nerve Stimulator - Headache

21 CFR 882.5892 / Neurology
FDA source (opens on fda.gov)

PKR is the FDA product code for Non-Invasive Vagus Nerve Stimulator - Headache, a class II device type, regulated under 21 CFR 882.5892. FDA's definition for this code reads: "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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PKR
Device name
Non-Invasive Vagus Nerve Stimulator - Headache
FDA definition
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.
Regulation
21 CFR 882.5892
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code PKR

By decision year
9 clearances under product code PKR with a decision year between 2017 and 2021, 2017 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PKR by decision year
YearClearances
20173
20183
20201
20212

Applicants with the most clearances

Product code PKR
Applicants holding the most 510(k) clearances under product code PKR
ApplicantClearances
Electrocore, Inc.8
Eletrocore, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code