Cleared Traditional

K201824 - Nerivio (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201824 · Theranica Bio-Electronics, Ltd. · Neurology device
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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
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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