Cleared Traditional

PTT 6200 ELEVATION THERAPY TABLE (K953622) - FDA 510(k) Clearance

Class I Physical Medicine device.

K953622 · U.S. Table, Inc. · Physical Medicine device
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Sep 1995
Decision
39d
Days
Class 1
Risk

K953622 is an FDA 510(k) clearance for the PTT 6200 ELEVATION THERAPY TABLE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by U.S. Table, Inc. (Glen Allen, US). The FDA issued a Cleared decision on September 11, 1995 after a review of 39 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 U.S. Table, Inc. devices

Submission Details

510(k) Number K953622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1995
Decision Date September 11, 1995
Days to Decision 39 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
76d faster than avg
Panel avg: 115d · This submission: 39d
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.