Not Cleared Direct

DEN180059 - Nerivio Migra (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180059 · Theranica Bioelectronics , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
195d
Days
Class 2
Risk

DEN180059 is an FDA 510(k) submission (not cleared) for the Nerivio Migra. Classified as Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine (product code QGT), Class II - Special Controls.

Submitted by Theranica Bioelectronics , Ltd. (Netanya, IL). The FDA issued a Not Cleared (DENG) decision on May 20, 2019 after a review of 195 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5899 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Theranica Bioelectronics , Ltd. devices

Submission Details

510(k) Number DEN180059 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 06, 2018
Decision Date May 20, 2019
Days to Decision 195 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 148d · This submission: 195d
Pathway characteristics

Device Classification

Product Code QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5899
Definition A Trunk And Limb Electrical Stimulator To Treat Headache Is A Device Intended To Treat Headache Through The Application Of Electrical Stimulation Anywhere On The Body Of The Patient Apart From The Patient's Head Or Neck Through Electrodes Placed On The Skin. The Stimulation May Be Provided Transcutaneously Or Percutaneously.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - QGT Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Devices cleared under the same product code (QGT) and FDA review panel - the closest regulatory comparables to DEN180059.
Nerivio
K250405 · Theranica Bio-Electronics, Ltd. · May 2025
Nerivio
K241756 · Theranica Bio-Electronics, Ltd. · Oct 2024
NerivioInfinity
K232152 · Theranica Bioelectronics , Ltd. · Nov 2023
Nerivio
K223169 · Theranica Bioelectronics , Ltd. · Feb 2023
Nerivio, FGD000075-4.7
K203181 · Theranica Bioelectronics , Ltd. · Jan 2021