Cleared Traditional

K844490 - TRACTION ACCESSORIES (FDA 510(k) Clearance)

Class I Physical Medicine device.

K844490 · Jerome Medical · Physical Medicine device
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Feb 1985
Decision
93d
Days
Class 1
Risk

K844490 is an FDA 510(k) clearance for the TRACTION ACCESSORIES. Classified as Accessories, Traction (product code ILZ), Class I - General Controls.

Submitted by Jerome Medical (Mt Laurel, US). The FDA issued a Cleared decision on February 21, 1985 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5925 - 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 Jerome Medical devices

Submission Details

510(k) Number K844490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1984
Decision Date February 21, 1985
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILZ Accessories, Traction
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5925
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.