Cleared Traditional

Portable Neuromodulation Stimulator (PoNS) (K253061) - FDA 510(k) Clearance

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

K253061 · Helius Medical, Inc. · Neurology device
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May 2026
Decision
233d
Days
Class 2
Risk

K253061 is an FDA 510(k) clearance for the Portable Neuromodulation Stimulator (PoNS). Classified as Electrical Tongue Stimulator To Treat Motor Deficits (product code QCF), Class II - Special Controls.

Submitted by Helius Medical, Inc. (Newton, US). The FDA issued a Cleared decision on May 13, 2026 after a review of 233 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5889 - 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 Helius Medical, Inc. devices

Submission Details

510(k) Number K253061 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2025
Decision Date May 13, 2026
Days to Decision 233 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
85d slower than avg
Panel avg: 148d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QCF Electrical Tongue Stimulator To Treat Motor Deficits
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5889
Definition An Electrical Tongue Nerve Stimulator To Treat Motor Deficits Is A Prescription Device That Consists Of A Non-implantable Apparatus To Generate Electrical Pulses For Stimulation Of The Nerves In The Tongue To Provide Treatment Of Motor Deficits.
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.