Cleared Traditional

K945676 - GUARDIAN DISPOSABLE TENS AND TENS/NMES ...

K945676 is the FDA 510(k) clearance for GUARDIAN DISPOSABLE TENS AND TENS/NMES ... by Selectivemed Components, Inc.. It is a Class 2 Neurology device (product code GZJ) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K945676 · Selectivemed Components, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
73d
Days
Class 2
Risk

K945676 is an FDA 510(k) clearance for the GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Selectivemed Components, Inc. (Mt. Vernon, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 73 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.

View all Selectivemed Components, Inc. devices

Submission Details

510(k) Number K945676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1994
Decision Date January 30, 1995
Days to Decision 73 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
75d faster than avg
Panel avg: 148d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
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