Cleared Traditional

K953982 - SIMPLEX TENS

K953982 is an FDA 510(k) clearance for SIMPLEX TENS, manufactured by Armstrong Industries, Inc.. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 611-day FDA review.

K953982 · Armstrong Industries, Inc. · Neurology device
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Apr 1997
Decision
611d
Days
Class 2
Risk

K953982 is an FDA 510(k) clearance for the SIMPLEX TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Armstrong Industries, Inc. (Plano, US). The FDA issued a Cleared decision on April 25, 1997 after a review of 611 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Armstrong Industries, Inc. devices

FDA 510(k) Submission Details - K953982

510(k) Number K953982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1995
Decision Date April 25, 1997
Days to Decision 611 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
463d slower than avg
Panel avg: 148d · This submission: 611d
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 184
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K953982.
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
K965244 · Z Technologies, LLC · Aug 1997
SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD
K965187 · Sparta Surgical Corp. · Aug 1997
BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T
K970429 · Apex Medical Corp. · Apr 1997
EPIX VT
K970203 · Empi · Apr 1997
S.P. 100
K970696 · Lsi Intl., Inc. · Mar 1997
SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
K963729 · Skylark Device Co., Ltd. · Feb 1997