Cleared Traditional

K942428 - CMT-1000

K942428 is an FDA 510(k) clearance for CMT-1000, manufactured by Ems, Inc.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 368-day FDA review.

K942428 · Ems, Inc. · Neurology device
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May 1995
Decision
368d
Days
Class 2
Risk

K942428 is an FDA 510(k) clearance for the CMT-1000. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Ems, Inc. (Pen Valley, US). The FDA issued a Cleared decision on May 23, 1995 after a review of 368 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 Ems, Inc. devices

FDA 510(k) Submission Details - K942428

510(k) Number K942428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1994
Decision Date May 23, 1995
Days to Decision 368 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
220d slower than avg
Panel avg: 148d · This submission: 368d
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 K942428.
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ISOTRON III
K941815 · Excel Tech. , Ltd. · May 1995
THERATOUCH 4.7
K932868 · Rich-Mar Corp. · Jul 1994
IF400
K930535 · Skylark Device Co., Ltd. · Jun 1994