Cleared Traditional

FT MODEL TABLE W/ELECTRIC HI LO OPTION E (K925563) - FDA 510(k) Clearance

Class I Physical Medicine device.

K925563 · Pro Med Mfg., Inc. · Physical Medicine device
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May 1993
Decision
204d
Days
Class 1
Risk

K925563 is an FDA 510(k) clearance for the FT MODEL TABLE W/ELECTRIC HI LO OPTION E. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Pro Med Mfg., Inc. (Blaine, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 204 days - an extended review 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: 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 Pro Med Mfg., Inc. devices

Submission Details

510(k) Number K925563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date May 26, 1993
Days to Decision 204 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
89d slower than avg
Panel avg: 115d · This submission: 204d
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.