Cleared Traditional

K851007 - GRAVITY TRACTION TABLE

K851007 is an FDA 510(k) clearance for GRAVITY TRACTION TABLE, manufactured by William F. Trinkaus. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K851007 · William F. Trinkaus · Physical Medicine device
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Jun 1985
Decision
101d
Days
Class 1
Risk

K851007 is an FDA 510(k) clearance for the GRAVITY TRACTION TABLE. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by William F. Trinkaus (East Detroit, US). The FDA issued a Cleared decision on June 21, 1985 after a review of 101 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 William F. Trinkaus devices

FDA 510(k) Submission Details - K851007

510(k) Number K851007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date June 21, 1985
Days to Decision 101 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 115d · This submission: 101d
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 49
Devices cleared under the same product code (INQ) and FDA review panel - the closest regulatory comparables to K851007.
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
HI-LO TILT TABLE 625
K850377 · Tri W-G, Inc. · May 1985
MODELS 841,842,843,851,852 & 853 ELEVATING TRACTIO
K844712 · Tri W-G, Inc. · Mar 1985
MOBILIZATIOIN TABLE
K841594 · Chattanooga Group, Inc. · May 1984