Cleared Traditional

K915100 - BRINDLEY & SMITH ET-1000

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

K915100 · Zmi Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 21
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K915100.
INTERFERENTIAL STIMULATOR MODEL IMF4150/A
K925687 · Biomedical Life Systems, Inc. · Mar 1993
INTELECT IFC2
K924666 · Chattanooga Group, Inc. · Mar 1993
ENDOMED 582
K922020 · Henley Intl. · Sep 1992
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