Cleared Traditional

K052204 - THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER

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

K052204 · Tzora Active Systems , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K052204

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.

INI Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K052204.
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
K063389 · Pride Mobility Products Corp. · Nov 2006
WU'S 3-WHEELED NEO SCOOTER, MODEL WT-T3E
K062790 · Wu'S Tech Co., Ltd. · Oct 2006
GO GO MINI, MODEL SC30
K062160 · Pride Mobility Products Corp. · Sep 2006
BREEZE
K051028 · Afikim Electric Vehicles · Jan 2006
VCS S3Y
K051130 · Cycling and Health Tech. Industry R&D Center/Chc · Sep 2005
VCS S3T
K051131 · Cycling and Health Tech. Industry R&D Center/Chc · Aug 2005