Cleared Traditional

K030375 - SOFT-TOUCH TENS ELECTRODE

K030375 is an FDA 510(k) clearance for SOFT-TOUCH TENS ELECTRODE, manufactured by Pain Management Technologies. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K030375 · Pain Management Technologies · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
90d
Days
Class 2
Risk

K030375 is an FDA 510(k) clearance for the SOFT-TOUCH TENS ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Pain Management Technologies (Akron, US). The FDA issued a Cleared decision on May 5, 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 882.1320 - 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 Pain Management Technologies devices

FDA 510(k) Submission Details - K030375

510(k) Number K030375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2003
Decision Date May 05, 2003
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 229
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K030375.
BIS PEDIATRIC SENSOR
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MYOSYSTEM WITH CUSTOMIZING
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LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
K012463 · Everyway Medical Instruments Co.,Ltd · Feb 2002
MODIFICATION TO:APEX MEDICAL IF-4100
K013813 · Apex Medical Corp. · Dec 2001