Cleared Traditional

K904823 - FLEXERCYCLE (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904823 · Medmetric Corp. · Physical Medicine device
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Jan 1991
Decision
97d
Days
Class 2
Risk

K904823 is an FDA 510(k) clearance for the FLEXERCYCLE. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Medmetric Corp. (San Diego, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 97 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.

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Submission Details

510(k) Number K904823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1990
Decision Date January 30, 1991
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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.