Cleared Traditional

THE EQUALIZER (K915369) - FDA 510(k) Clearance

Class I Physical Medicine device.

K915369 · Advanced Rehabilitative Technology, Inc. · Physical Medicine device
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Mar 1993
Decision
481d
Days
Class 1
Risk

K915369 is an FDA 510(k) clearance for the THE EQUALIZER. Classified as Transducer, Miniature Pressure (product code IKE), Class I - General Controls.

Submitted by Advanced Rehabilitative Technology, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 22, 1993 after a review of 481 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1615 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Advanced Rehabilitative Technology, Inc. devices

Submission Details

510(k) Number K915369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date March 22, 1993
Days to Decision 481 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
366d slower than avg
Panel avg: 115d · This submission: 481d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IKE Transducer, Miniature Pressure
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.1615
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.