Cleared Traditional

MAC LEE SITZ BATH (K841711) - FDA 510(k) Clearance

Class I Physical Medicine device.

K841711 · Mac Lee Medical Products · Physical Medicine device
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May 1984
Decision
13d
Days
Class 1
Risk

K841711 is an FDA 510(k) clearance for the MAC LEE SITZ BATH. Classified as Bath, Sitz, Nonpowered (product code KTC), Class I - General Controls.

Submitted by Mac Lee Medical Products (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5125 - 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.

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Submission Details

510(k) Number K841711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1984
Decision Date May 07, 1984
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTC Bath, Sitz, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5125
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.