Cleared Traditional

K850377 - HI-LO TILT TABLE 625

K850377 is an FDA 510(k) clearance for HI-LO TILT TABLE 625, 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 91-day FDA review.

K850377 · Tri W-G, Inc. · Physical Medicine device
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May 1985
Decision
91d
Days
Class 1
Risk

K850377 is an FDA 510(k) clearance for the HI-LO TILT TABLE 625. 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 May 1, 1985 after a review of 91 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 - K850377

510(k) Number K850377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1985
Decision Date May 01, 1985
Days to Decision 91 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
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 K850377.
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
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO
K844712 · Tri W-G, Inc. · Mar 1985
MOBILIZATIOIN TABLE
K841594 · Chattanooga Group, Inc. · May 1984
TABLE, MODELS 610,611 & 612
K834103 · Tri W-G, Inc. · Jan 1984