Cleared Traditional

ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 (K932233) - FDA 510(k) Clearance

Class I Physical Medicine device.

K932233 · Bailey Mfg. Co. · Physical Medicine device
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Jul 1993
Decision
76d
Days
Class 1
Risk

K932233 is an FDA 510(k) clearance for the ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405. Classified as Table, Mechanical (product code INW), Class I - General Controls.

Submitted by Bailey Mfg. Co. (Lodi, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3750 - 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 Bailey Mfg. Co. devices

Submission Details

510(k) Number K932233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1993
Decision Date July 22, 1993
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INW Table, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3750
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.