Cleared Traditional

K243613 - Patch-TEA (Model TRI-21)

K243613 is an FDA 510(k) clearance for Patch-TEA (Model TRI-21), manufactured by Transtimulation Research, Inc.. The device is a Class 2 Neurology device with product code NUH cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K243613 · Transtimulation Research, Inc. · Neurology device
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Apr 2025
Decision
138d
Days
Class 2
Risk

K243613 is an FDA 510(k) clearance for the Patch-TEA (Model TRI-21). Classified as Stimulator, Nerve, Transcutaneous, Over-the-counter (product code NUH), Class II - Special Controls.

Submitted by Transtimulation Research, Inc. (Oklahoma City, US). The FDA issued a Cleared decision on April 9, 2025 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 Transtimulation Research, Inc. devices

FDA 510(k) Submission Details - K243613

510(k) Number K243613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2024
Decision Date April 09, 2025
Days to Decision 138 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
10d faster than avg
Panel avg: 148d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUH Device Classification - Class 2, Special Controls

Product Code NUH Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Temporary Relief Of Pain Due To Sore/aching Muscles
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 - NUH Stimulator, Nerve, Transcutaneous, Over-the-counter

All 149
Devices cleared under the same product code (NUH) and FDA review panel - the closest regulatory comparables to K243613.
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