Cleared Traditional

K870712 - MULTI-FLEX TABLE -- MODEL 103

K870712 is the FDA 510(k) clearance for MULTI-FLEX TABLE -- MODEL 103 by Slenderizers Equipment Mfg., Inc.. It is a Class 2 Physical Medicine device (product code JFB) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K870712 · Slenderizers Equipment Mfg., Inc. · Physical Medicine device
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Jun 1987
Decision
109d
Days
Class 2
Risk

K870712 is an FDA 510(k) clearance for the MULTI-FLEX TABLE -- MODEL 103. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Slenderizers Equipment Mfg., Inc. (Arnold, US). The FDA issued a Cleared decision on June 9, 1987 after a review of 109 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 Slenderizers Equipment Mfg., Inc. devices

Submission Details

510(k) Number K870712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1987
Decision Date June 09, 1987
Days to Decision 109 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
6d faster than avg
Panel avg: 115d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K870712.
745-M (MAGNUM)
K922980 · Tri W-G, Inc. · Jul 1992
IST-200 INTERSEGMENTAL TRACTION TABLE
K900304 · Chattanooga Group, Inc. · Apr 1990
HI-LO TABLE, MODEL 820-05
K882917 · Tri W-G, Inc. · Jul 1988
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