Cleared Traditional

K865054 - STIMUTRON MODEL 100

K865054 is the FDA 510(k) clearance for STIMUTRON MODEL 100 by The Austin-Lenick Co.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K865054 · The Austin-Lenick Co. · Physical Medicine device
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Feb 1987
Decision
64d
Days
Class 2
Risk

K865054 is an FDA 510(k) clearance for the STIMUTRON MODEL 100. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by The Austin-Lenick Co. (Ft. Myers, US). The FDA issued a Cleared decision on February 26, 1987 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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 The Austin-Lenick Co. devices

Submission Details

510(k) Number K865054 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 24, 1986
Decision Date February 26, 1987
Days to Decision 64 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 150
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K865054.
MYOSTIM(TM), MODEL 6600
K872753 · Medical Devices, Inc. · Oct 1987
INTELECT MODEL 575
K872654 · Chattanooga Group, Inc. · Sep 1987
DYNATRON 438
K870515 · Henley Intl. · Jun 1987
MYOPAC (TM), MODEL 9600
K864625 · Medical Devices, Inc. · Dec 1986
EMPI MODEL 712, LOGIX(TM), NMS
K864010 · Empi · Dec 1986
INTERSTIM 100 SYSTEM
K861136 · Buckman Co., Inc. · Jul 1986