Cleared Traditional

K203181 - Nerivio, FGD000075-4.7 (FDA 510(k) Clearance)

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

K203181 · Theranica Bioelectronics , Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Jan 2021
Decision
88d
Days
Class 2
Risk

K203181 is an FDA 510(k) clearance for the Nerivio, FGD000075-4.7. 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 Cleared decision on January 22, 2021 after a review of 88 days - a notably fast clearance cycle.

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: 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 Theranica Bioelectronics , Ltd. devices

Submission Details

510(k) Number K203181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2020
Decision Date January 22, 2021
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 M. 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
NCT04089761 Terminated Interventional Industry-sponsored

Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

A Single Arm, Open Label, Multicenter Study of the Safety and Efficacy of Nerivio™ for the Acute Treatment of Migraine in Adolescents

60
Patients (actual)
12
Sites
Treatment
Purpose
Open label
Masking
Condition studied Acute Migraine
Study design Single group
Eligibility All sexes · 12 Years+
Principal investigator Andrew Hershey, MD
Sponsor Theranica (industry)
Started 2019-10-01 → Primary completion 2020-05-10 → Completed 2020-05-24
Primary outcome
Safety of Nerivio Device
Secondary outcome
Pain Relief at 2 Hours Post Treatment
View full study on ClinicalTrials.gov