Cleared Traditional

K032928 - MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1

K032928 is an FDA 510(k) clearance for MEDIPHYSICS PAIN TREATMENT SYSTEM, manufactured by Mediphysics Pain Centers of America. 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.

K032928 · Mediphysics Pain Centers of America · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
88d
Days
Class 2
Risk

K032928 is an FDA 510(k) clearance for the MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Mediphysics Pain Centers of America (Lake Forest, US). The FDA issued a Cleared decision on December 19, 2003 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.

FDA 510(k) Submission Details - K032928

510(k) Number K032928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date December 19, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 149d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 589
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K032928.
EASY MED TN-28 C
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PREMIER PLUS
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K032994 · Gemore Technology Co, Ltd. · Dec 2003
GEM-STIM TENS, MODELS GM3XY AND GM3AXY
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K032928 · MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
Download PDF FDA Summary Mediphysics Pain Cent…