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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 149d · 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 72
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K032719.
INFINITY ELECTROTHERAPY SYSTEM
K042057 · Empi · Dec 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · Biomedical Life Systems, Inc. · Jul 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K033358 · Surgitech, Inc. · Nov 2003
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
K024100 · Theratech, Inc. · Feb 2003
NEOGENESYS 2K
K022433 · Sanexas Intl. GmbH · Jan 2003
K032719 · GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
Download PDF FDA Summary Gemore Technology Co,…