Cleared Traditional

K883896 - NEUROTRAIN

K883896 is an FDA 510(k) clearance for NEUROTRAIN, manufactured by Sterne Equipment Co., Ltd.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K883896 · Sterne Equipment Co., Ltd. · Neurology device
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Jul 1989
Decision
303d
Days
Class 2
Risk

K883896 is an FDA 510(k) clearance for the NEUROTRAIN. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Sterne Equipment Co., Ltd. (Brampton, On., CA). The FDA issued a Cleared decision on July 14, 1989 after a review of 303 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 Sterne Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K883896

510(k) Number K883896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1988
Decision Date July 14, 1989
Days to Decision 303 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 148d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIH Device Classification - Class 2, Special Controls

Product Code LIH Interferential Current Therapy
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 - LIH Interferential Current Therapy

All 35
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K883896.
ISOTRON III
K921954 · Excel Tech. , Ltd. · Aug 1992
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
K921441 · Biomedical Life Systems, Inc. · May 1992
ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A
K905571 · Biomedical Life Systems, Inc. · May 1991
IF-II (TM), MODEL 9800
K883462 · Medical Devices, Inc. · May 1989
SYS*STIM 220
K883080 · Mettler Electronics Corp. · Apr 1989
ENDOMED 433
K870384 · Henley Intl. · Apr 1988