FREERIDER MODEL LUGGIE MODEL 168-4IT

K110165 · Freerider Luggie Scooters, Inc. · INI · Sep 30, 2011 · Physical Medicine

Device Facts

• Record ID: K110165
• Device Name: FREERIDER MODEL LUGGIE MODEL 168-4IT
• Applicant: Freerider Luggie Scooters, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The Freerider Model Luggie is a motorized scooter which provides transportation for an elderly or disabled person. It can be in a variety of indoor and outdoor settings.

Device Story

The Freerider Luggie is a battery-operated, three-wheeled motorized scooter designed for mobility assistance. It features a platform, adjustable tiller, and seat. The rider operates the device via hand controls located on the tiller. The scooter is foldable into a single unit for transport in a vehicle trunk. It is intended for use by elderly or disabled individuals in various indoor and outdoor environments. The device utilizes a 0.1 horsepower motor and a regenerative braking system. It is provided with a battery and charger. The device assists users by providing a means of personal transportation, thereby enhancing mobility.

Clinical Evidence

No clinical data or comparative performance testing were submitted as part of this 510(k). Substantial equivalence was established based on bench testing conducted in accordance with the 1995 FDA Guidance Document for Mechanical and powered wheelchairs and Motorized Three Wheeled Vehicles.

Technological Characteristics

Battery-operated three-wheeled scooter; 0.1 horsepower motor; regenerative braking system; adjustable tiller; foldable frame. No specific material standards or software algorithms described.

Indications for Use

Indicated for elderly or disabled persons requiring transportation assistance in indoor and outdoor settings.

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.

Predicate Devices

• Tzora Active Systems Ltd – Easy Travel Elite (K110145)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K110145

## Submitter's Name: JEFFREY L DAVIS

SEP 3 0 2011

FreeRider Corporation No.22, Bengong 510 Road, Kang-Shan Town Kaohsiung County 820, Taiwan

NOVEMEBR 15st, 2010 Date summary prepared Device name:

> Proprietary name: Common or usual name: Classification name:

Electric scooter Motorized three-wheeled vehicle, Class II, 21 CFR 890.3800.

Legally marketed device for substantial equivalence comparison:

Tzora Active Systems Ltd –Easy Travel Elite submitted by Tzore Active Systems , Inc, Kibbutz , Tzora

Freerider Luggie

Description of the device:

The Freerider Model Luggie is a motorized three wheeled scooter which is battery operated. It consists of a platform which connects the three wheels, an adjustable tiller, and seat for the rider. It is driven by the rider using hand controls located at the top of the tiller. It can be simply folds under five steps into one unit for transport in a car trunk. It is provided with a battery & a battery charger.

Intended use of device:

The device provides transportation for an elderly or disabled person. It can be used in variety of indoor and outdoor settings.

Technological characteristics:

The device features and use parameters of the Freerider and Tzora scooters are very similar. Both are battery operated, have 0.1 horsepower motors, and have regenerative brake systems. Batteries capacity and battery chargers are similar and are provided with the scooters. Use parameters are very similar, varying only in minor parameters such as the grade climbable by the respective scooters.

Testing conducted:

Tests listed in the Guidance Document for the preparation of market Notification [510(k)] Applications for Mechanical and powered wheelchairs, and Motorized Three Wheeled Vehicles, July1995, were conducted and the results included in the subject 510(k) submission.

Performance testing:

Comparative performance testing and clinical evaluations were not submitted as part of this 510(k).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002

SEP 30 2011

FreeRider Luggie Scooters. Inc. % Diagnostic Medical Consultant Mr. Jeffrey L. Davis 4500 Country Glen Court Riverside, CA 92505

Re: K110165

Trade/Device Name: FreeRider Luggie Regulation Number: 21 CFR 890,3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 24, 2011 Received: August 24, 2011

Dear Mr. Davis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly ability warranties. We remind you, however, that device labeling must be truthful and not micheading.

!f your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 that FDA has made a determination that your device complies with other requirements not the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Mr. Jeffrey L. Davis

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pari 803), please go to

http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Freerider TM Model Luggie ' ' 510(k) Notification Page 4

Indications for Statement

KI10165 510(k) Number ( if known): ___________________________________________________________________________________________________________________________________________________

Device name: Freerider Luggie

Indications for Use:

The Freerider Model Luggie is a motorized scooter which provides transportation for an elderly or disabled person. It can be in a variety of indoor and outdoor settings. -

(Please do not write below this line)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Divis Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110165

Prescription Use_ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use_ OR

( Per 21 CFR 801.109)