Cleared Traditional

K894154 - METABOLIC SYSTEMS

K894154 is the FDA 510(k) clearance for METABOLIC SYSTEMS by Cybex. It is a Class 2 Physical Medicine device (product code ISD) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K894154 · Cybex · Physical Medicine device
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Oct 1989
Decision
132d
Days
Class 2
Risk

K894154 is an FDA 510(k) clearance for the METABOLIC SYSTEMS. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on October 24, 1989 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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 Cybex devices

Submission Details

510(k) Number K894154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1989
Decision Date October 24, 1989
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - ISD Exerciser, Measuring

All 15
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