Cleared Traditional

AQUATREX UNDERWATER TREADMILL SYSTEM (K895104) - FDA 510(k) Clearance

Class I Physical Medicine device.

K895104 · Edmonds Medical Systems · Physical Medicine device
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Dec 1989
Decision
111d
Days
Class 1
Risk

K895104 is an FDA 510(k) clearance for the AQUATREX UNDERWATER TREADMILL SYSTEM. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Edmonds Medical Systems (Edmonds, US). The FDA issued a Cleared decision on December 4, 1989 after a review of 111 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.

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Submission Details

510(k) Number K895104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date December 04, 1989
Days to Decision 111 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
4d faster than avg
Panel avg: 115d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOL Treadmill, 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.