K203419 is an FDA 510(k) clearance for the Relivion. Classified as Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC), Class II - Special Controls.
Submitted by Neurolief , Ltd. (Netanya, IL). The FDA issued a Cleared decision on February 16, 2021 after a review of 89 days - a notably fast clearance cycle.
This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5891 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.
View all Neurolief , Ltd. devices
NCT02438553
Completed
Interventional
Industry-sponsored
Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain
A Prospective, Randomized, Single Blind, Parallel-group, Placebo Controlled Clinical Study to Evaluate the Short-term Effectiveness of Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation (OS-TNS) in Reducing Migraine Related Pain
| Condition studied |
Headache, Migraine |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Rachel Hering, Dr. |
| Sponsor |
Neurolief Ltd.
(industry)
|
Started 2015-05-01
→
Primary completion 2015-10-01
Primary outcome
Pain visual analogue scale (VAS)
Secondary outcome
"Responder" rate at 20-60 minutes of treatment.
Study completed - no results published.
This trial concluded in 2015 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov