Cleared Traditional

K032003 - PREMIER PLUS

K032003 is an FDA 510(k) clearance for PREMIER PLUS, manufactured by American Imex. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K032003 · American Imex · Neurology device
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Jan 2004
Decision
194d
Days
Class 2
Risk

K032003 is an FDA 510(k) clearance for the PREMIER PLUS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by American Imex (Irvine, US). The FDA issued a Cleared decision on January 7, 2004 after a review of 194 days - an extended review 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: 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 - K032003

510(k) Number K032003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2003
Decision Date January 07, 2004
Days to Decision 194 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 149d · This submission: 194d
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 605
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K032003.
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294
K023916 · Bio-Medical Research, Ltd. · Apr 2004
EASY MED TN-28 C
K040253 · Easy Med Instrument Co., Ltd. · Apr 2004
ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5
K033455 · Biomedical Life Systems, Inc. · Jan 2004
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
K032928 · Mediphysics Pain Centers of America · Dec 2003
T-TECH DIGITAL, MODEL WL-22XXA SERIES
K033857 · Well-Life Healthcare, Inc. · Dec 2003
GM3 SERIES HV TENS, MODEL GM3X3HV (WHERE X IS PARAMETER OF DIFFERENT HOUSING)
K032994 · Gemore Technology Co, Ltd. · Dec 2003
K032003 · PREMIER PLUS
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