Cleared Special

K212106 - Relivion (FDA 510(k) Clearance)

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

K212106 · Neurolief , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
27d
Days
Class 2
Risk

K212106 is an FDA 510(k) clearance for the Relivion. Classified as Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC), Class II - Special Controls.

Submitted by Neurolief , Ltd. (Netanya, IL). The FDA issued a Cleared decision on August 2, 2021 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5891 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neurolief , Ltd. devices

Submission Details

510(k) Number K212106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2021
Decision Date August 02, 2021
Days to Decision 27 days
Submission Type Special
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
121d faster than avg
Panel avg: 148d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5891
Definition Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.
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 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.

Regulatory Peers - PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

All 17
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