Cleared Traditional

TRACTION SYSTEM, DIGIT-TRAC 930 (K052453) - FDA 510(k) Clearance

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

K052453 · Ever Prosperous Instrument, Inc. · Physical Medicine device
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Jan 2006
Decision
128d
Days
Class 2
Risk

K052453 is an FDA 510(k) clearance for the TRACTION SYSTEM, DIGIT-TRAC 930. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Ever Prosperous Instrument, Inc. (Hsin-Chu City, TW). The FDA issued a Cleared decision on January 13, 2006 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5900 - 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 Ever Prosperous Instrument, Inc. devices

Submission Details

510(k) Number K052453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2005
Decision Date January 13, 2006
Days to Decision 128 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITH Equipment, Traction, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5900
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 - ITH Equipment, Traction, Powered

All 70
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