EASYTRAVEL

K012592 · Tzora Active Systems , Ltd. · INI · Oct 3, 2001 · Physical Medicine

Device Facts

• Record ID: K012592
• Device Name: EASYTRAVEL
• Applicant: Tzora Active Systems , Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Oct 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

Mobility assistive device for indoor use and outdoor use on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.

Device Story

EasyTravel is a motorized three-wheeled vehicle designed as a mobility assistive device. It provides powered mobility for users in indoor environments and on mild outdoor terrain. The device is not intended for use on public roads or freeways. It functions as a personal mobility aid to assist individuals with limited mobility in navigating their surroundings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; Class II device; Product Code INI; Regulation 890.3800.

Indications for Use

Indicated for individuals requiring mobility assistance for indoor and outdoor use on mild terrain. Contraindicated for use as a transportation vehicle on roads and freeways.

Regulatory Classification

Identification

A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2001

Tzora Active Systems, Ltd. c/o Mr. Mark Job 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, Minnesota 55112

Re: K012592

Trade/Device Name: EasyTravel Regulation Number: 890.3800 Regulation Name: Motorized three wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 20, 2001 Received: August 21, 2001

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 ass stated in the encreates)76, the enactment date of the Medical Device Amendments, or to conninered pror to rial) 2011-07-12, in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tou may, diereleve, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow you to begal finding of substantial equivalence of your device to a legally premarket notification: "The PDF interessification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific actrice to: 75cm vitro diagnostic devices), please contact the Office of additionally 21 CFTC Fat 0071. I dditionally, for questions on the promotion and advertising of Compliance at [phone]. The news.com/liance at [phone]. Also, please note the your do recess, pread comable by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Thisoranians on your responsibilities under the Act may be obtained from the Other general monmactor on your ternational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KOI 2592

Device Name: EasyTravel

Indications For Use:

Mobility assistive device for indoor use and outdoor use on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) (Division Sign-Off) (Division Sign-Oil)
Division o General, Restorative Division of Schoological Devices 510(k) Number .

SK22