Cleared Traditional

K926391 - ACCUFLEX DYNAMIC ELBOW ORTHOSIS (FDA 510(k) Clearance)

Class I Physical Medicine device.

K926391 · Regulatory & Marketing Services, Inc. · Physical Medicine device
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Jul 1993
Decision
213d
Days
Class 1
Risk

K926391 is an FDA 510(k) clearance for the ACCUFLEX DYNAMIC ELBOW ORTHOSIS. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Florida, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 213 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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 K926391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date July 22, 1993
Days to Decision 213 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
98d slower than avg
Panel avg: 115d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
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.