Cleared Traditional

K932236 - PRO. HI-LOW TABLE MODEL 9530

K932236 is an FDA 510(k) clearance for PRO. HI-LOW TABLE MODEL 9530, manufactured by Bailey Mfg. Co.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K932236 · Bailey Mfg. Co. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jul 1993
Decision
76d
Days
Class 1
Risk

K932236 is an FDA 510(k) clearance for the PRO. HI-LOW TABLE MODEL 9530. Classified as Table, Powered (product code INQ), 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 890.3760 - 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 Bailey Mfg. Co. devices

FDA 510(k) Submission Details - K932236

510(k) Number K932236 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.

INQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - INQ Table, Powered

All 49
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K932236.
POWERMATIC TREATMENT TABLE
K933581 · Medical Device Inspection Co., Inc. · Nov 1993
HI-LO TREATMENT TABLES
K933119 · Tri W-G, Inc. · Oct 1993
POWERMATIC EXAMINATION TABLE
K933577 · Medical Device Inspection Co., Inc. · Sep 1993
MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE
K932746 · Tri W-G, Inc. · Jul 1993
THE HILL ADJUSTABLE HA90
K931832 · Hill Laboratories Co. · Jun 1993
MODELS 642 & 643 TILT EXAM/TREATMENT TABLE
K930802 · Tri W-G, Inc. · Mar 1993