Cleared Traditional

K023443 - MEDS-3 NEUROMUSCULAR STIMULATOR

K023443 is an FDA 510(k) clearance for MEDS-3 NEUROMUSCULAR STIMULATOR, 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 90-day FDA review.

K023443 · Medical Equipment Device Specialists · Neurology device
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Jan 2003
Decision
90d
Days
Class 2
Risk

K023443 is an FDA 510(k) clearance for the MEDS-3 NEUROMUSCULAR STIMULATOR. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medical Equipment Device Specialists (San Juan Capistrano, US). The FDA issued a Cleared decision on January 13, 2003 after a review of 90 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 - K023443

510(k) Number K023443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date January 13, 2003
Days to Decision 90 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
59d faster than avg
Panel avg: 149d · This submission: 90d
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 K023443.
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
MEDS-4 NEUROMUSCULAR STIMULATOR
K023435 · Medical Equipment Device Specialists · Jan 2003
THE IZZZY-TENS (WL-2401), THE SLIM-TENS (WL-2402), THE MENS-TENS (WL2403), THE COMPACT TENS (WL-2302)
K020020 · Well-Life Healthcare, Inc. · Dec 2002
SANIDAD TENS-DUO MODE GP8016N
K021430 · Rolor Electronics Corp. · Dec 2002
804SIII
K021846 · Body Clock Health Care, Ltd. · Nov 2002
K023443 · MEDS-3 NEUROMUSCULAR STIMULATOR
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