Cleared Traditional

K891118 - STERLING TENS

K891118 is an FDA 510(k) clearance for STERLING 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 188-day FDA review.

K891118 · Armstrong Industries, Inc. · Neurology device
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Sep 1989
Decision
188d
Days
Class 2
Risk

K891118 is an FDA 510(k) clearance for the STERLING TENS. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Armstrong Industries, Inc. (Richardson, US). The FDA issued a Cleared decision on September 6, 1989 after a review of 188 days - an extended review 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: 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 Armstrong Industries, Inc. devices

FDA 510(k) Submission Details - K891118

510(k) Number K891118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date September 06, 1989
Days to Decision 188 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 148d · This submission: 188d
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 K891118.
TTS2700 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR
K895211 · Henley Intl. · Oct 1989
TTS2600
K895334 · Henley Intl. · Oct 1989
TENZCARE STIMULATOR 6890
K891992 · 3M Company · Oct 1989
TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR
K884972 · Futuremed Div. of Future Impex Corp. · Jul 1989
MODIFIED MRL NEUROPROBE SYSTEM V
K884869 · Medical Research Laboratories, Inc. · Jun 1989
EMPI, MODEL 489, TENS
K890604 · Empi · Jun 1989