Cleared Traditional

ORLAU SWIVEL WALKER (K923880) - FDA 510(k) Clearance

Class I Physical Medicine device.

K923880 · Mopac, Ltd. · Physical Medicine device
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Sep 1996
Decision
1522d
Days
Class 1
Risk

K923880 is an FDA 510(k) clearance for the ORLAU SWIVEL WALKER. Classified as Orthosis, Truncal/orthosis, Limb (product code MRI), Class I - General Controls.

Submitted by Mopac, Ltd. (Eau Claire, US). The FDA issued a Cleared decision on September 30, 1996 after a review of 1522 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Mopac, Ltd. devices

Submission Details

510(k) Number K923880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1992
Decision Date September 30, 1996
Days to Decision 1522 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1407d slower than avg
Panel avg: 115d · This submission: 1522d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRI Orthosis, Truncal/orthosis, Limb
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
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.