Cleared Traditional

K032719 - GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)

K032719 is an FDA 510(k) clearance for GM3 SERIES IF TENS, manufactured by Gemore Technology Co, Ltd.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K032719 · Gemore Technology Co, Ltd. · Neurology device
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Dec 2003
Decision
99d
Days
Class 2
Risk

K032719 is an FDA 510(k) clearance for the GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING). Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Gemore Technology Co, Ltd. (Tan Shui, Taipei Hsien, TW). The FDA issued a Cleared decision on December 10, 2003 after a review of 99 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 Gemore Technology Co, Ltd. devices

FDA 510(k) Submission Details - K032719

510(k) Number K032719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date December 10, 2003
Days to Decision 99 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
49d faster than avg
Panel avg: 148d · This submission: 99d
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 42
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