Cleared Traditional

K905756 - TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE

K905756 is an FDA 510(k) clearance for TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE, manufactured by Titan Technology Intl., Inc.. The device is a Class 2 Physical Medicine device with product code JFB cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K905756 · Titan Technology Intl., Inc. · Physical Medicine device
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Jan 1991
Decision
12d
Days
Class 2
Risk

K905756 is an FDA 510(k) clearance for the TITAN MERIDIAN INTERSEGMENTAL ROLLERTABLE. Classified as Table, Physical Therapy, Multi Function (product code JFB), Class II - Special Controls.

Submitted by Titan Technology Intl., Inc. (St. Louis, US). The FDA issued a Cleared decision on January 8, 1991 after a review of 12 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 Titan Technology Intl., Inc. devices

FDA 510(k) Submission Details - K905756

510(k) Number K905756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date January 08, 1991
Days to Decision 12 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
103d faster than avg
Panel avg: 115d · This submission: 12d
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 K905756.
TRUE-TRAC, STRATUS
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