Cleared Traditional

K013167 - MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500

K013167 is an FDA 510(k) clearance for MODEL7500 MICROCURRENT TENS DEVICE, manufactured by Newcare Products, LLC. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K013167 · Newcare Products, LLC · Neurology device
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Jan 2002
Decision
131d
Days
Class 2
Risk

K013167 is an FDA 510(k) clearance for the MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Newcare Products, LLC (Rockville, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 131 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 Newcare Products, LLC devices

FDA 510(k) Submission Details - K013167

510(k) Number K013167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2001
Decision Date January 30, 2002
Days to Decision 131 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
17d faster than avg
Panel avg: 148d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 236
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K013167.
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K012848 · Rich-Mar Corp. · Oct 2001
MULTI-STIM, MODEL MS-100
K001897 · Metron Medical Australia, Pty, Ltd. · Jun 2001