Cleared Traditional

K202725 - ETD4000

K202725 is an FDA 510(k) clearance for ETD4000, manufactured by Therasigma, LLC. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K202725 · Therasigma, LLC · Neurology device
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Mar 2021
Decision
190d
Days
Class 2
Risk

K202725 is an FDA 510(k) clearance for the ETD4000. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Therasigma, LLC (Washougal, US). The FDA issued a Cleared decision on March 26, 2021 after a review of 190 days - an extended review cycle.

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 Therasigma, LLC devices

FDA 510(k) Submission Details - K202725

510(k) Number K202725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2020
Decision Date March 26, 2021
Days to Decision 190 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 148d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - LIH Interferential Current Therapy

All 31
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K202725.
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INFINITY ELECTROTHERAPY SYSTEM
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