Cleared Traditional

K052204 - THE ELITE - ULTRA-LIGHT

K052204 is the FDA 510(k) clearance for THE ELITE - ULTRA-LIGHT by Tzora Active Systems , Ltd.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K052204 · Tzora Active Systems , Ltd. · Physical Medicine device
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Feb 2006
Decision
187d
Days
Class 2
Risk

K052204 is an FDA 510(k) clearance for the THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Tzora Active Systems , Ltd. (Kibbutz Tzora, IL). The FDA issued a Cleared decision on February 15, 2006 after a review of 187 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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 Tzora Active Systems , Ltd. devices

Submission Details

510(k) Number K052204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2005
Decision Date February 15, 2006
Days to Decision 187 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
72d slower than avg
Panel avg: 115d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

All 80
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