Cleared Traditional

THE SPRITZ BATH (K912179) - FDA 510(k) Clearance

Class I Physical Medicine device.

K912179 · The Spritz Co. · Physical Medicine device
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Aug 1991
Decision
104d
Days
Class 1
Risk

K912179 is an FDA 510(k) clearance for the THE SPRITZ BATH. Classified as Bath, Sitz, Nonpowered (product code KTC), Class I - General Controls.

Submitted by The Spritz Co. (Houston, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 104 days - within the typical 510(k) review window.

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: 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 The Spritz Co. devices

Submission Details

510(k) Number K912179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1991
Decision Date August 28, 1991
Days to Decision 104 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
11d faster than avg
Panel avg: 115d · This submission: 104d
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.