Cleared Traditional

K030140 - DUOMED, SERIES 500, (MODELS ID 500, FL 500)

K030140 is an FDA 510(k) clearance for DUOMED, manufactured by Duomed, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K030140 · Duomed, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
63d
Days
Class 2
Risk

K030140 is an FDA 510(k) clearance for the DUOMED, SERIES 500, (MODELS ID 500, FL 500). Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Duomed, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on March 18, 2003 after a review of 63 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 - K030140

510(k) Number K030140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2003
Decision Date March 18, 2003
Days to Decision 63 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 149d · This submission: 63d
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 K030140.
CARE STIM
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K030537 · Well-Life Healthcare, Inc. · Mar 2003
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
K021270 · Biomedical Life Systems · Feb 2003
ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-3
K021271 · Biomedical Life Systems · Feb 2003
TATUNG TMD-26AX SERIES TENS, MODELS NO. TMD-26AB TATUNG TENS (BLUE HOUSING) TMD-26AY TATUNG TENS (YELLOW HOUSING)
K021794 · Tatung Co. · Jan 2003
K030140 · DUOMED, SERIES 500, (MODELS ID 500, FL 500)
Download PDF FDA Summary Duomed, Inc.