Cleared Traditional

K941815 - ISOTRON III

K941815 is an FDA 510(k) clearance for ISOTRON III, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Neurology device with product code LIH cleared through the Traditional 510(k) pathway after a 386-day FDA review.

K941815 · Excel Tech. , Ltd. · Neurology device
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May 1995
Decision
386d
Days
Class 2
Risk

K941815 is an FDA 510(k) clearance for the ISOTRON III. Classified as Interferential Current Therapy (product code LIH), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on May 3, 1995 after a review of 386 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 Excel Tech. , Ltd. devices

FDA 510(k) Submission Details - K941815

510(k) Number K941815 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 12, 1994
Decision Date May 03, 1995
Days to Decision 386 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 148d · This submission: 386d
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 42
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K941815.
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THERATOUCH 4.7
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IF400
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INTERFERENTIAL STIMULATOR MODEL IMF4150/A
K925687 · Biomedical Life Systems, Inc. · Mar 1993