Cleared Traditional

K955860 - MULTI III

K955860 is the FDA 510(k) clearance for MULTI III by Excel Tech. , Ltd.. It is a Class 2 Neurology device (product code LIH) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K955860 · Excel Tech. , Ltd. · Neurology device
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Mar 1996
Decision
86d
Days
Class 2
Risk

K955860 is an FDA 510(k) clearance for the MULTI III, IV. 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 March 22, 1996 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Excel Tech. , Ltd. devices

Submission Details

510(k) Number K955860 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 27, 1995
Decision Date March 22, 1996
Days to Decision 86 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
62d faster than avg
Panel avg: 148d · This submission: 86d
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 K955860.
INTERFERENTIAL STIMULATOR, MODEL BMLS02-6
K040007 · Biomedical Life Systems, Inc. · Jul 2004
INTERFERENTIAL STIMULATOR, MODEL BMLS03-6
K040824 · Biomedical Life Systems, Inc. · Apr 2004
ISOTRON III, ISOTRON IV
K955387 · Excel Tech. , Ltd. · Mar 1996
RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
K952089 · Rich-Mar Corp. · Aug 1995
ISOTRON III
K941815 · Excel Tech. , Ltd. · May 1995
THERATOUCH 4.7
K932868 · Rich-Mar Corp. · Jul 1994