Cleared Traditional

K792269 - WRIGHT DOW CORNING SOFTGOODS W/DOW (FDA 510(k) Clearance)

Class I Physical Medicine device.

K792269 · Dow Corning Wright · Physical Medicine device
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Feb 1980
Decision
88d
Days
Class 1
Risk

K792269 is an FDA 510(k) clearance for the WRIGHT DOW CORNING SOFTGOODS W/DOW. Classified as Orthosis, Lumbo-sacral (product code IPY), Class I - General Controls.

Submitted by Dow Corning Wright (Walker, US). The FDA issued a Cleared decision on February 5, 1980 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dow Corning Wright devices

Submission Details

510(k) Number K792269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1979
Decision Date February 05, 1980
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IPY Orthosis, Lumbo-sacral
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.