Cleared Traditional

Nerivio (K201824) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence.

K201824 · Theranica Bio-Electronics, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
114d
Days
Class 2
Risk

K201824 is an FDA 510(k) clearance for the Nerivio. Classified as Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine (product code QGT), Class II - Special Controls.

Submitted by Theranica Bio-Electronics, Ltd. (Netanya, IL). The FDA issued a Cleared decision on October 23, 2020 after a review of 114 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Theranica Bio-Electronics, Ltd. devices

Submission Details

510(k) Number K201824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2020
Decision Date October 23, 2020
Days to Decision 114 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Neurology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04161807 Completed Interventional Industry-sponsored

Efficacy and Safety of Nerivio™ for Acute Treatment of Migraine in People With Chronic Migraine

Efficacy and Safety of Nerivio™, a Remote Electrical Neuromodulation Device, for Acute Treatment of Migraine in People With Chronic Migraine: an Open Label, Single Arm, Multicenter Study

42
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Chronic Migraine
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Paul Wright
Sponsor Theranica (industry)
Started 2019-09-18 → Primary completion 2020-02-18
Primary outcome
Proportion of Participants With Reduction of Migraine Headache at 2 Hours Post Treatment
Secondary outcome
Proportion of Participants With Pain Disappearance at 2 Hours Post Treatment
View full study on ClinicalTrials.gov

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 K201824.
NerivioInfinity
K232152 · Theranica Bioelectronics , Ltd. · Nov 2023
Nerivio
K223169 · Theranica Bioelectronics , Ltd. · Feb 2023
Nerivio, FGD000075-4.7
K203181 · Theranica Bioelectronics , Ltd. · Jan 2021
Nerivio Migra
DEN180059 · Theranica Bioelectronics , Ltd. · May 2019