Cleared Traditional

THE LEADAWAY (K992372) - FDA 510(k) Clearance

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

K992372 · Therapy Equipment, Inc. · Physical Medicine device
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Oct 1999
Decision
90d
Days
Class 2
Risk

K992372 is an FDA 510(k) clearance for the THE LEADAWAY. Classified as Cable, Electrode (product code IKD), Class II - Special Controls.

Submitted by Therapy Equipment, Inc. (West Palm Beach, US). The FDA issued a Cleared decision on October 13, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1175 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Therapy Equipment, Inc. devices

Submission Details

510(k) Number K992372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1999
Decision Date October 13, 1999
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKD Cable, Electrode
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1175
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.