Cleared Traditional

K012592 - EASYTRAVEL

K012592 is the FDA 510(k) clearance for EASYTRAVEL by Tzora Active Systems , Ltd.. It is a Class 2 Physical Medicine device (product code INI) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K012592 · Tzora Active Systems , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 80
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K012592.
MEDLINE STRIDER MIDI 3
K040097 · Medline Industries, Inc. · Feb 2004
MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
K032446 · Medline Industries, Inc. · Feb 2004
INVACARE ADVENTURE SERIES SCOOTERS, MODELS ADVENTURE SX-3 & LX-3
K030814 · Invacare Corp. · Mar 2003
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS, MODELS LYNX SX-3, LYNX SX-3P, LYNX LX-3, LYNX LX-3, PANTHER LX-4
K010135 · Invacare Corp. · Feb 2001
MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
K992052 · Invacare Corp. · Aug 1999
TRI-ROLLS REAR WHEEL DRIVE POWERED SCOOTER
K901586 · Invacare Corp. · Apr 1990