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

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 149d · 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 588
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K013167.
CLASSIC TENS
K020437 · Care Rehab, Inc. · Mar 2002
ENRAF-NONIUS ENDOMED 182 SYSTEM
K003744 · Henley Healthcare, Inc. · Feb 2002
APEX MEDICAL MINI TENS
K020032 · Apex Medical Corp. · Jan 2002
COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH
K013507 · Cosmo Health, Inc. · Jan 2002
STRESS GUARD, MODEL HERDEV1
K004008 · Herbo Medex International, Inc. · Dec 2001
APEX MEDICAL LCD TENS-VII
K012643 · Apex Medical Corp. · Oct 2001
K013167 · MODEL7500 MICROCURRENT TENS DEVICE, MCT-F5, MCT-F50, MCT-F500
Download PDF FDA Summary Newcare Products, LLC