Cleared Traditional

K012592 - EASYTRAVEL

K012592 is an FDA 510(k) clearance for EASYTRAVEL, 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 54-day FDA review.

K012592 · Tzora Active Systems , Ltd. · Physical Medicine device
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Oct 2001
Decision
54d
Days
Class 2
Risk

K012592 is an FDA 510(k) clearance for the EASYTRAVEL. 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 October 3, 2001 after a review of 54 days - a notably fast clearance 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: 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 Tzora Active Systems , Ltd. devices

FDA 510(k) Submission Details - K012592

510(k) Number K012592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2001
Decision Date October 03, 2001
Days to Decision 54 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K012592.
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