Cleared Traditional

K943973 - EURO TECH STERLING ROLLER TABLE

K943973 is an FDA 510(k) clearance for EURO TECH STERLING ROLLER TABLE, manufactured by Progressive Electrical Therapeutics. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K943973 · Progressive Electrical Therapeutics · Physical Medicine device
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Sep 1994
Decision
45d
Days
Class 2
Risk

K943973 is an FDA 510(k) clearance for the EURO TECH STERLING ROLLER TABLE. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Progressive Electrical Therapeutics (Nevada, US). The FDA issued a Cleared decision on September 29, 1994 after a review of 45 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 Progressive Electrical Therapeutics devices

FDA 510(k) Submission Details - K943973

510(k) Number K943973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date September 29, 1994
Days to Decision 45 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
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 K943973.
P.T. MACHINE
K974626 · Goodman, Goodman & Goodman · Feb 1998
HANDIFLEX
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THE HILL ADJUSTABLE AIR-FLEX MODEL
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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