Cleared Traditional

MIDLAND THREE SECTION P.T. TABLE W/ DRAINAGE (K924002) - FDA 510(k) Clearance

Class I Physical Medicine device.

K924002 · Midland Mfg. Co. · Physical Medicine device
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Nov 1992
Decision
91d
Days
Class 1
Risk

K924002 is an FDA 510(k) clearance for the MIDLAND THREE SECTION P.T. TABLE W/ DRAINAGE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Midland Mfg. Co. (Great Neck, US). The FDA issued a Cleared decision on November 9, 1992 after a review of 91 days - within the typical 510(k) review window.

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: 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.

View all Midland Mfg. Co. devices

Submission Details

510(k) Number K924002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1992
Decision Date November 09, 1992
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
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.