Cleared Traditional

K092546 - GMDASZ TENS ELECTRODES

K092546 is an FDA 510(k) clearance for GMDASZ TENS ELECTRODES, manufactured by Gmdasz Manufacturing Co., Ltd.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K092546 · Gmdasz Manufacturing Co., Ltd. · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2009
Decision
121d
Days
Class 2
Risk

K092546 is an FDA 510(k) clearance for the GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.D.... Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Gmdasz Manufacturing Co., Ltd. (Echo, US). The FDA issued a Cleared decision on December 18, 2009 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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.

View all Gmdasz Manufacturing Co., Ltd. devices

FDA 510(k) Submission Details - K092546

510(k) Number K092546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date December 18, 2009
Days to Decision 121 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 148d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 221
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K092546.
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