Cleared Traditional

K920585 - MAT TABLE

K920585 is an FDA 510(k) clearance for MAT TABLE, manufactured by Tri W-G, Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K920585 · Tri W-G, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
57d
Days
Class 1
Risk

K920585 is an FDA 510(k) clearance for the MAT TABLE, 8100 SERIES MAT PLATFORM. 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 April 7, 1992 after a review of 57 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 Tri W-G, Inc. devices

FDA 510(k) Submission Details - K920585

510(k) Number K920585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date April 07, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
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 20
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K920585.
MODELS 642 & 643 TILT EXAM/TREATMENT TABLE
K930802 · Tri W-G, Inc. · Mar 1993
MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE
K925594 · Tri W-G, Inc. · Feb 1993
MODEL 600 MEDICAL TREATMENT TABLE
K923325 · Tri W-G, Inc. · Jul 1992
POWER PODIATRY CHAIR/TABLE #414, #416 & #417
K894017 · Midmark Corp. · Jul 1989
HLE-1000 HIGH/LOW TREATMENT TABLE
K883659 · Rich-Mar Corp. · Oct 1988
R1698,R1701,R1215,R1700 & R860 POWERED TABLES
K861352 · Tri W-G, Inc. · May 1986