Cleared Traditional

K936303 - TREATMENT TABLE MODIFICATION (FDA 510(k) Clearance)

Class I Physical Medicine device.

K936303 · Tri W-G, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
119d
Days
Class 1
Risk

K936303 is an FDA 510(k) clearance for the TREATMENT TABLE MODIFICATION. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on March 18, 1994 after a review of 119 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 Tri W-G, Inc. devices

Submission Details

510(k) Number K936303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1993
Decision Date March 18, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
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.