Cleared Traditional

K921954 - ISOTRON III

K921954 is the FDA 510(k) clearance for ISOTRON III by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code LIH) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K921954 · Excel Tech. , Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
121d
Days
Class 2
Risk

K921954 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 August 26, 1992 after a review of 121 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K921954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1992
Decision Date August 26, 1992
Days to Decision 121 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 148d · This submission: 121d
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 19
Devices cleared under the same product code (LIH) and FDA review panel - the closest regulatory comparables to K921954.
INTELECT IFC2
K924666 · Chattanooga Group, Inc. · Mar 1993
ENDOMED 582
K922020 · Henley Intl. · Sep 1992
MULTI III
K921953 · 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