Cleared Traditional

K926316 - TRUE-TRAC, STRATUS

K926316 is an FDA 510(k) clearance for TRUE-TRAC, manufactured by Henley Intl.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K926316 · Henley Intl. · Physical Medicine device
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Mar 1993
Decision
99d
Days
Class 2
Risk

K926316 is an FDA 510(k) clearance for the TRUE-TRAC, STRATUS. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on March 24, 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 890.5880 - 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 Henley Intl. devices

FDA 510(k) Submission Details - K926316

510(k) Number K926316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1992
Decision Date March 24, 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. No clinical trials required.

JFB Device Classification - Class 2, Special Controls

Product Code JFB Table, Physical Therapy, Multi Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - JFB Table, Physical Therapy, Multi Function

All 29
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K926316.
P.T. MACHINE
K974626 · Goodman, Goodman & Goodman · Feb 1998
HANDIFLEX
K971046 · Handiflex Corp. · Sep 1997
THE HILL ADJUSTABLE AIR-FLEX MODEL
K932810 · Hill Laboratories Co. · Feb 1995
TRACTION TABLE MODEL #825-200
K930259 · Biodan Medical Systems, Ltd. · Mar 1993
745-M (MAGNUM)
K922980 · Tri W-G, Inc. · Jul 1992
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · Chattanooga Group, Inc. · Apr 1990