Cleared Traditional

K844359 - MOBILIZATION & TRACTION TABLE (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844359 · Chattanooga Group, Inc. · Physical Medicine device
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Feb 1985
Decision
91d
Days
Class 2
Risk

K844359 is an FDA 510(k) clearance for the MOBILIZATION & TRACTION TABLE. Classified as Elevator, Wheelchair, Portable (product code ING), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Red Bank, US). The FDA issued a Cleared decision on February 12, 1985 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3930 - 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 Chattanooga Group, Inc. devices

Submission Details

510(k) Number K844359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date February 12, 1985
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ING Elevator, Wheelchair, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3930
Definition A Motorized Lift Device That Is Not Permanently Mounted In One Location And That Is Intended For Medical Purposes To Provide A Means To Move A Person With Impaired Mobility, With Or Without A Wheelchair, From One Level To Another (e.g., Portable Platform Lifts, Attendant-operated Stair Climbing Devices For Wheelchairs).
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.