Cleared Traditional

STIMUTRON MODEL 100 (K865054) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

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