Cleared Traditional

K946230 - ENDURA REUSABLE TENS AND NMES ELECTRODES

K946230 is an FDA 510(k) clearance for ENDURA REUSABLE TENS AND NMES ELECTRODES, manufactured by Selectivemed Components, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 365-day FDA review.

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

FDA 510(k) Submission Details - K946230

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.

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 211
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K946230.
GALVA 5-T
K960969 · Zimmer Elektromedizin GmbH · May 1996
EPIX XL TENS UNIT
K951903 · Empi · Mar 1996
ACUPLUS
K954334 · S.H.P. Intl. Pty., Ltd. · Jan 1996
PGS123 AND HVS-123
K946299 · Skylark Device Co., Ltd. · Jun 1995
BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)
K934051 · Skylark Device Co., Ltd. · Jul 1994
STAT-TENS
K931079 · Skylark Device Co., Ltd. · Jun 1994