Cleared Traditional

K922719 - WILLIAMS ADVANTAGE ELEVATION TABLE

K922719 is the FDA 510(k) clearance for WILLIAMS ADVANTAGE ELEVATION TABLE by Williams Manufacturing Co.. It is a Class 1 Physical Medicine device (product code INQ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K922719 · Williams Manufacturing Co. · Physical Medicine device
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Aug 1992
Decision
63d
Days
Class 1
Risk

K922719 is an FDA 510(k) clearance for the WILLIAMS ADVANTAGE ELEVATION TABLE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Williams Manufacturing Co. (Elgin, US). The FDA issued a Cleared decision on August 7, 1992 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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 Williams Manufacturing Co. devices

Submission Details

510(k) Number K922719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1992
Decision Date August 07, 1992
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
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.

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