Cleared Traditional

K904950 - MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES

K904950 is an FDA 510(k) clearance for MANUAL AND MOTORIZED FLEXION DISTRACTIO..., manufactured by Leander Research, Mfg & Distr., Inc.. The device is a Class 1 Physical Medicine device with product code INQ cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K904950 · Leander Research, Mfg & Distr., Inc. · Physical Medicine device
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Nov 1990
Decision
24d
Days
Class 1
Risk

K904950 is an FDA 510(k) clearance for the MANUAL AND MOTORIZED FLEXION DISTRACTION TABLES. Classified as Table, Powered (product code INQ), Class I - General Controls.

Submitted by Leander Research, Mfg & Distr., Inc. (Port Orchard, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3760 - 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 Leander Research, Mfg & Distr., Inc. devices

FDA 510(k) Submission Details - K904950

510(k) Number K904950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1990
Decision Date November 26, 1990
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

INQ Device Classification - Class 1, General Controls

Product Code INQ Table, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - INQ Table, Powered

All 49
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