LANDLEX, MODEL S300X

K050792 · Cycling and Health Tech. Industry R&D Center · INI · Apr 21, 2005 · Physical Medicine

Device Facts

• Record ID: K050792
• Device Name: LANDLEX, MODEL S300X
• Applicant: Cycling and Health Tech. Industry R&D Center
• Product Code: INI · Physical Medicine
• Decision Date: Apr 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

LANDLEX S300X scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device Story

Motorized three-wheeled scooter; provides mobility for disabled/elderly persons in seated position. Input: user operation via tiller handle and thumb-operated potentiometer throttle control. Operation: battery-powered rear-wheel drive; welded steel frame; sealed transaxle motor; electromagnetic braking system; electric motor controller. Output: physical transportation; max speed 8 km/hr (5 mph); 35 km range. Used in indoor/outdoor environments; operated by patient. Includes auto light sensor and lighting system. Benefits: provides independent mobility for users with limited walking ability.

Clinical Evidence

Bench testing only. Device tested for static stability (ISO 7176-1), speed/acceleration/deceleration (ISO 7176-6), structural strength (ISO 7176-8), electromagnetic compatibility (ISO 7176-21, CISPR 11, IEC 61000-4-2/3), and flammability (California Bureau of Home Furnishings 116).

Technological Characteristics

Welded steel frame; rear-wheel drive; two 12V lead-acid DC batteries; sealed transaxle motor; electromagnetic braking; thumb-operated potentiometer throttle. Dimensions/weight capacity: 135 kg (300 lbs). Standards: ANSI/RESNA WC/Vol.1, ISO 7176 series, IEC 61000 series, CISPR 11. Auto light sensor included.

Indications for Use

Indicated for disabled or elderly persons limited to a seated position requiring indoor/outdoor mobility assistance.

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

• Be-Mobile 3-Wheeled Electric Scooter, DK S320 (K033241)

Submission Summary (Full Text)

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K050792

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#### 7. 510(k) summary

## 510(k) Summary

# Besteam Technology Inc.

### LANDLEX S300X scooter

Proprietary and Manufacturer information: Besteam Technology Inc. No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan Registration number: 3005004555 Contact person: Jack Chen, QA engineer of R&D Department Phone: [phone] Facsimile: [phone] e-mail: [e-mail] Date prepared: March 23, 2005

#### Device

Trade name: LANDLEX S300X scooter Common name: Electrical scooter Classification name: Motorized three-wheeled vehicle Medical specialty (Panel): Physical Medicine Device Regulation number: 890.3800 Product Code: 89INI Classification: Class II

#### Predicate devices

Manufacture name: TUNG DENG ENTERPRISE CO., LTD. Name: Be-Mobile 3-Wheeled Electric Scooter, DK S320 k number: K033241 Date cleared: 11/10/2003

#### Intend use of device

LANDLEX S300X scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

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K050792

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#### Device description:

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The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The LANDLEX S300X scooter is with a 135 kg (300 lbs) weight capacity.

The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a auto light sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat.

It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The scooter is powered by two 12 volt lead-acid DC batteries with 35 km (22 miles) with 34AH which maximum speed upto 8 km/hr (5 mph).

#### Substantial equivalence:

The LANDLEX S300X scooter is substantially equivalent to the Be-Mobile 3-Wheeled Electric Scooter, DK S320 (K033241) manufactured by TUNG DENG ENTERPRISE CO., LTD..

Analysis of comparison of design, function and feature of LANDLEX S300X scooter to TUNG DENG DK S320 (K033241), together with the results of compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended.

While there are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness. Therefore, Besteam believes that the LANDLEX S300X scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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### Non-Clinical testing

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LANDLEX S300X scooter has been tested to wheelchair standards. They include:

- (1). ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
- (2). ANSI/RESNA WC/Vo1.1 section 6-1998 / ISO7176-6-2001 Determination of max speed, acceleration and deceleration of electric wheelchair
- (3). ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
- (4). ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
- (5). CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics – limits and methods of measurement
- (6). IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
- (7). IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
- (8). California Bureau of Home Furnishings 116 Flammability Standards.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare.

Public Health Service

APR 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cycling and Health Tech. Industry R&D Center/CHC C/o Mr. Jack Chen Besteam Technology, Inc. No.16-1, Ziqiang 181 Road Zhongli, Taoyuan Hsien 32063 (Taiwan)

Re: K050792

Trade/Device Name: LANDLEX S300X Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: March 23, 2005 Received: March 28, 2005

Dear Mr. Chen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 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. Jack Chen

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter watification. The FDA finding of substantial equivalence of your device to a legally proficated predicate device results in a classification 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), please 11 you attent of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golleral informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hypt. Rlurches

riam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 3. Device descriptive information 3.1 Statement of indication for use

## Statement of Indications for Use

510(k) Number (if known):

Device Name: LANDLEX S300X

Indications for Use:

.

The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Stept Plurdes
Division Sign-Off

Division of General, Restorative and Neurological Devices

**510(k) Number** K050792

(Posted November 13, 2003)