Cleared Traditional

K844490 - TRACTION ACCESSORIES

K844490 is an FDA 510(k) clearance for TRACTION ACCESSORIES, manufactured by Jerome Medical. The device is a Class 1 Physical Medicine device with product code ILZ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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.

FDA 510(k) Submission Details - K844490

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
23d faster than avg
Panel avg: 116d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

ILZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - ILZ Accessories, Traction

All 11
Devices cleared under the same product code (ILZ) and FDA review panel - the closest regulatory comparables to K844490.
FLEXION DISTRATION SUPPORT
K921711 · Altoona Medical Supply · Jul 1992
VIBRA-TRAC TRACTION TABLE
K895382 · Vibra-Trac Industries · Oct 1989
AMX-110, AMX-II AND AMX-III
K884340 · Dyna-Med · Jan 1989
SAUNDERS #7080 CERVICAL TRACTION SYS
K831135 · Chattanooga Group, Inc. · Jun 1983
HEAD HALTER
K830245 · Warm & Form, Orthopedic Materials · Mar 1983
PELVIC TRACTION BELT
K823659 · Warm & Form, Orthopedic Materials · Dec 1982
K844490 · TRACTION ACCESSORIES
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