Cleared Traditional

AQUACISER IN-POOL TREADMILL (K925807) - FDA 510(k) Clearance

Class I Physical Medicine device.

K925807 · Aquaciser, Inc. · Physical Medicine device
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Mar 1993
Decision
128d
Days
Class 1
Risk

K925807 is an FDA 510(k) clearance for the AQUACISER IN-POOL TREADMILL. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Aquaciser, Inc. (Vail, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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 Aquaciser, Inc. devices

Submission Details

510(k) Number K925807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1992
Decision Date March 24, 1993
Days to Decision 128 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
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.