Cleared Traditional

K925594 - MDL 29001 MEDI ELEC-MECH TILT EXAM/TREA...

K925594 is an FDA 510(k) clearance for MDL 29001 MEDI ELEC-MECH TILT EXAM/TREA..., 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 99-day FDA review.

K925594 · Tri W-G, Inc. · Physical Medicine device
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Feb 1993
Decision
99d
Days
Class 1
Risk

K925594 is an FDA 510(k) clearance for the MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE. 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 February 12, 1993 after a review of 99 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

FDA 510(k) Submission Details - K925594

510(k) Number K925594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date February 12, 1993
Days to Decision 99 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
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 K925594.
POWERMATIC EXAMINATION TABLE
K933577 · Medical Device Inspection Co., Inc. · Sep 1993
MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE
K932746 · Tri W-G, Inc. · Jul 1993
MODELS 642 & 643 TILT EXAM/TREATMENT TABLE
K930802 · Tri W-G, Inc. · Mar 1993
MODEL 600 MEDICAL TREATMENT TABLE
K923325 · Tri W-G, Inc. · Jul 1992
MAT TABLE, 8100 SERIES MAT PLATFORM
K920585 · Tri W-G, Inc. · Apr 1992
POWER PODIATRY CHAIR/TABLE #414, #416 & #417
K894017 · Midmark Corp. · Jul 1989