Cleared Traditional

K032055 - MEDS-4-INF+

K032055 is an FDA 510(k) clearance for MEDS-4-INF+, manufactured by Medical Equipment Device Specialists. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K032055 · Medical Equipment Device Specialists · Neurology device
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Oct 2003
Decision
93d
Days
Class 2
Risk

K032055 is an FDA 510(k) clearance for the MEDS-4-INF+. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Equipment Device Specialists (Las Vegas, US). The FDA issued a Cleared decision on October 3, 2003 after a review of 93 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 - K032055

510(k) Number K032055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2003
Decision Date October 03, 2003
Days to Decision 93 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
56d faster than avg
Panel avg: 149d · This submission: 93d
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 589
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K032055.
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K023726 · Acumed Medical Supplies , Ltd. · Jun 2003
K032055 · MEDS-4-INF+
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