Cleared Traditional

K102278 - QUADRA BLOC TENS PLUS

K102278 is an FDA 510(k) clearance for QUADRA BLOC TENS PLUS, manufactured by Gradient Technologies, LLC. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 435-day FDA review.

K102278 · Gradient Technologies, LLC · Neurology device
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Oct 2011
Decision
435d
Days
Class 2
Risk

K102278 is an FDA 510(k) clearance for the QUADRA BLOC TENS PLUS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Gradient Technologies, LLC (Memphis, US). The FDA issued a Cleared decision on October 20, 2011 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Gradient Technologies, LLC devices

FDA 510(k) Submission Details - K102278

510(k) Number K102278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2010
Decision Date October 20, 2011
Days to Decision 435 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
287d slower than avg
Panel avg: 148d · This submission: 435d
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 175
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K102278.
SENSUS
K130919 · Neurometrix, Inc. · Jul 2013
SENSUS
K121184 · Neurometrix, Inc. · Aug 2012
NEUROTECH PLUS
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KNEEHAB XP
K110350 · Bio-Medical Research, Ltd. · Aug 2011
4 CHANNELS MULTIPLE MODEL DIGITAL ELECTRICAL STIMULATOR, MODEL NUVOSTIM IV, WL-2504A
K100399 · Well-Life Healthcare Limited · Jun 2010
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K092448 · Hivox Biotek, Inc. · Mar 2010