Cleared Traditional

K051028 - BREEZE

K051028 is an FDA 510(k) clearance for BREEZE, manufactured by Afikim Electric Vehicles. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K051028 · Afikim Electric Vehicles · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
280d
Days
Class 2
Risk

K051028 is an FDA 510(k) clearance for the BREEZE. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Afikim Electric Vehicles (Kibbutz Afikim, IL). The FDA issued a Cleared decision on January 27, 2006 after a review of 280 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.

FDA 510(k) Submission Details - K051028

510(k) Number K051028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2005
Decision Date January 27, 2006
Days to Decision 280 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
164d slower than avg
Panel avg: 116d · This submission: 280d
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 332
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K051028.
AVANTICARE, MODEL SA4021
K060068 · Lerado China Limited · Mar 2006
THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
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LANDLEX, MODEL P100X
K060042 · Besteam Technology, Inc. · Feb 2006
VCS, MODEL S4T
K052558 · Cycling and Health Tech. Industry R&D Center/Chc · Oct 2005
KING I POWERED SCOOTER, MODEL CTL-11
K052673 · King I Tech Corporation · Oct 2005
PROASIA, MODEL L3402
K052378 · Proasia Limited · Oct 2005
K051028 · BREEZE
Download PDF FDA Summary Afikim Electric Vehic…