Cleared Traditional

K882917 - HI-LO TABLE

K882917 is an FDA 510(k) clearance for HI-LO TABLE, manufactured by Tri W-G, Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K882917 · Tri W-G, Inc. · Physical Medicine device
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Jul 1988
Decision
16d
Days
Class 2
Risk

K882917 is an FDA 510(k) clearance for the HI-LO TABLE, MODEL 820-05. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Tri W-G, Inc. (Valley City, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 16 days - a notably fast clearance cycle.

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: 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 - K882917

510(k) Number K882917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1988
Decision Date July 28, 1988
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 15
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K882917.
TRUE-TRAC, STRATUS
K926316 · Henley Intl. · Mar 1993
745-M (MAGNUM)
K922980 · Tri W-G, Inc. · Jul 1992
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · Chattanooga Group, Inc. · Apr 1990
KINETIC AUTO TECHNIC K.A.T. TABLE
K851328 · Buckman Co., Inc. · Jul 1985
AUTOTRACTION TABLE
K844233 · Chattanooga Group, Inc. · Dec 1984
PDB II VIBRATING DRAINAGE BED
K843572 · Invacare Corp. · Nov 1984