Cleared Traditional

K250405 - Nerivio (FDA 510(k) Clearance)

Also includes:
Nerivio Infinity

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

K250405 · Theranica Bio-Electronics, Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
90d
Days
Class 2
Risk

K250405 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 May 14, 2025 after a review of 90 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 K250405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2025
Decision Date May 14, 2025
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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
NCT05464069 Completed Observational Industry-sponsored

Safety of Nerivio in Pregnant Women With Migraine

A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum

145
Patients (actual)
2
Sites
Condition studied Migraine; Pregnancy Related
Eligibility Female only · 18 Years+ · Healthy volunteers accepted
Principal investigator Alit Stark Inbar, PhD
Sponsor Theranica (industry)
Started 2022-08-01 → Primary completion 2022-11-28 → Completed 2022-12-07
Primary outcome
Gestational Age at Delivery
Secondary outcome
Birth Weight
View full study on ClinicalTrials.gov