Cleared Traditional

K915100 - BRINDLEY & SMITH ET-1000

K915100 is an FDA 510(k) clearance for BRINDLEY & SMITH ET-1000, manufactured by Zmi Corp.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K915100 · Zmi Corp. · Neurology device
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Sep 1992
Decision
307d
Days
Class 2
Risk

K915100 is an FDA 510(k) clearance for the BRINDLEY & SMITH ET-1000. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Zmi Corp. (Taiwan, HK). The FDA issued a Cleared decision on September 14, 1992 after a review of 307 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 Zmi Corp. devices

FDA 510(k) Submission Details - K915100

510(k) Number K915100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1991
Decision Date September 14, 1992
Days to Decision 307 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
159d slower than avg
Panel avg: 148d · This submission: 307d
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 45
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K915100.
INTELECT IFC2
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DYNATRON 400
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ENDOMED 582
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MULTI III
K921953 · Excel Tech. , Ltd. · Aug 1992
ISOTRON III
K921954 · Excel Tech. , Ltd. · Aug 1992
INTERFERENTIAL STIMULATOR MODEL INF 4150/A
K921441 · Biomedical Life Systems, Inc. · May 1992