Cleared Traditional

THE MASSAGER (K924315) - FDA 510(k) Clearance

Class I Physical Medicine device.

K924315 · Four Directions · Physical Medicine device
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Oct 1993
Decision
408d
Days
Class 1
Risk

K924315 is an FDA 510(k) clearance for the THE MASSAGER. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Four Directions (Seattle, US). The FDA issued a Cleared decision on October 8, 1993 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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 Four Directions devices

Submission Details

510(k) Number K924315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1992
Decision Date October 08, 1993
Days to Decision 408 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
293d slower than avg
Panel avg: 115d · This submission: 408d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYG Massager, Therapeutic, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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.