Cleared Traditional

K923103 - JT-1 POWERED TRACTION UNIT

K923103 is an FDA 510(k) clearance for JT-1 POWERED TRACTION UNIT, manufactured by Chirotronics, Inc.. The device is a Class 2 Physical Medicine device with product code ITH cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K923103 · Chirotronics, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
137d
Days
Class 2
Risk

K923103 is an FDA 510(k) clearance for the JT-1 POWERED TRACTION UNIT. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Chirotronics, Inc. (Asheville, US). The FDA issued a Cleared decision on November 9, 1992 after a review of 137 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 Chirotronics, Inc. devices

FDA 510(k) Submission Details - K923103

510(k) Number K923103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1992
Decision Date November 09, 1992
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITH Device Classification - Class 2, Special Controls

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.