Cleared Traditional

K102304 - BREEZE C MODEL C (3W), BREEZE C (4W)

K102304 is an FDA 510(k) clearance for BREEZE C MODEL C (3W), 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 144-day FDA review.

K102304 · Afikim Electric Vehicles · Physical Medicine device
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Jan 2011
Decision
144d
Days
Class 2
Risk

K102304 is an FDA 510(k) clearance for the BREEZE C MODEL C (3W), BREEZE C (4W). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Afikim Electric Vehicles. The FDA issued a Cleared decision on January 7, 2011 after a review of 144 days - within the typical 510(k) review window.

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 - K102304

510(k) Number K102304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2010
Decision Date January 07, 2011
Days to Decision 144 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 116d · This submission: 144d
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
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K102304 · BREEZE C MODEL C (3W), BREEZE C (4W)
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