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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 116d · 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 Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 354
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K012592.
SOVEREIGN
K011476 · Shoprider Intl., Inc. · Oct 2001
C.T.M. MOBILITY SCOOTER MODEL # HS-320
K012791 · Warepalmy Enterprise, LLC (Usa) · Oct 2001
C.T.M. MOBITIY SCOOTER MODEL #HS-360
K012792 · Warepalmy Enterprise, LLC (Usa) · Oct 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011751 · Merits Health Products., Inc. · Aug 2001
TRAVEL EASE ELECTRIC SCOOTER MODEL # PIONEER 2
K011707 · Merits Medical Industries Co., Ltd. · Aug 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
K011753 · Merits Health Products., Inc. · Aug 2001

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K012592 · EASYTRAVEL
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