Cleared Traditional

ENDURA REUSABLE TENS AND NMES ELECTRODES (K946230) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946230 · Selectivemed Components, Inc. · Neurology device
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Dec 1995
Decision
365d
Days
Class 2
Risk

K946230 is an FDA 510(k) clearance for the ENDURA REUSABLE TENS AND 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 December 22, 1995 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Selectivemed Components, Inc. devices

Submission Details

510(k) Number K946230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1994
Decision Date December 22, 1995
Days to Decision 365 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
217d slower than avg
Panel avg: 148d · This submission: 365d
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 605
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