Cleared Traditional

K041520 - MANTRA TENS MODEL NT3

K041520 is an FDA 510(k) clearance for MANTRA TENS MODEL NT3, manufactured by Mantra Intl. (Hk) , Ltd.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K041520 · Mantra Intl. (Hk) , Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Sep 2004
Decision
88d
Days
Class 2
Risk

K041520 is an FDA 510(k) clearance for the MANTRA TENS MODEL NT3. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Mantra Intl. (Hk) , Ltd. (Chatsworth, US). The FDA issued a Cleared decision on September 3, 2004 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mantra Intl. (Hk) , Ltd. devices

FDA 510(k) Submission Details - K041520

510(k) Number K041520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date September 03, 2004
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 186
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K041520.
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS06-1
K061476 · Biomedical Life Systems, Inc. · Jul 2006
MODEL BMLS03-7
K042711 · Biomedical Life Systems, Inc. · Mar 2005
COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1
K041388 · Biomedical Life Systems, Inc. · Nov 2004
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · Bio-Medical Research, Ltd. · Apr 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · Biomedical Life Systems, Inc. · Jan 2004
NEUROTECH BAXOLVE TYPE 294
K023913 · Bio-Medical Research, Ltd. · Aug 2003