Cleared Traditional

K901526 - PRO TREATMENT TABLE

K901526 is an FDA 510(k) clearance for PRO TREATMENT TABLE, manufactured by R&R Ent., Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K901526 · R&R Ent., Inc. · Physical Medicine device
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Apr 1990
Decision
18d
Days
Class 2
Risk

K901526 is an FDA 510(k) clearance for the PRO TREATMENT TABLE. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by R&R Ent., Inc. (Mcallen, US). The FDA issued a Cleared decision on April 20, 1990 after a review of 18 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 R&R Ent., Inc. devices

FDA 510(k) Submission Details - K901526

510(k) Number K901526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1990
Decision Date April 20, 1990
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
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 33
Devices cleared under the same product code (JFB) and FDA review panel - the closest regulatory comparables to K901526.
TRUE-TRAC, STRATUS
K926316 · Henley Intl. · Mar 1993
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
HI-LO TABLE, MODEL 820-05
K882917 · Tri W-G, Inc. · Jul 1988
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE
K862022 · Lic-Orthion · Jun 1986