Cleared Traditional

K862846 - TEC VARI-TRAC II TRACTION UNIT

K862846 is the FDA 510(k) clearance for TEC VARI-TRAC II TRACTION UNIT by Therapeutic Equipment Corp.. It is a Class 2 Physical Medicine device (product code ITH) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K862846 · Therapeutic Equipment Corp. · Physical Medicine device
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Aug 1986
Decision
9d
Days
Class 2
Risk

K862846 is an FDA 510(k) clearance for the TEC VARI-TRAC II TRACTION UNIT. Classified as Equipment, Traction, Powered (product code ITH), Class II - Special Controls.

Submitted by Therapeutic Equipment Corp. (Clifton, US). The FDA issued a Cleared decision on August 7, 1986 after a review of 9 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Therapeutic Equipment Corp. devices

Submission Details

510(k) Number K862846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date August 07, 1986
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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.