LANDLEX MODEL S400X

K050793 · Cycling and Health Tech. Industry R&D Center · INI · Jul 7, 2005 · Physical Medicine

Device Facts

• Record ID: K050793
• Device Name: LANDLEX MODEL S400X
• Applicant: Cycling and Health Tech. Industry R&D Center
• Product Code: INI · Physical Medicine
• Decision Date: Jul 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The LANDLEX S400X 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.

Device Story

The LANDLEX S400X is a battery-powered, three-wheeled motorized scooter designed for indoor and outdoor mobility for disabled or elderly users. The device features a welded steel frame, adjustable seat, and tiller steering. Operation is controlled via a thumb-operated potentiometer throttle lever, which regulates speed and direction (forward/reverse) through an electric motor controller. Braking is managed by an electromagnetic system. The scooter is powered by two 12V lead-acid batteries, supporting a maximum speed of 9 km/hr and a weight capacity of 135 kg. It includes an automatic headlight sensor and lighting system. The device is intended for patient self-operation to facilitate independent transportation.

Clinical Evidence

Bench testing only. The device underwent performance testing per ANSI/RESNA and ISO 7176 standards, including static stability, speed/acceleration/deceleration, and structural strength (static, impact, fatigue). Electromagnetic compatibility was verified per ISO 7176-21, CISPR 11, and IEC 61000 series. Flammability testing was conducted per California Bureau of Home Furnishings 116 standards.

Technological Characteristics

Welded steel frame; battery-powered (two 12V lead-acid); sealed transaxle motor drive; electromagnetic braking; thumb-operated potentiometer throttle; tiller steering. Standards: ANSI/RESNA WC/Vol.1, ISO 7176-1/6/8/21, IEC 61000-4-2/3, CISPR 11. Connectivity: None. Sterilization: N/A.

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

• Bewell SC 20 (K043326)

Submission Summary (Full Text)

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7. 510(k) summary

JUL 7 - 2005

K050793

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# 510(k) Summary Besteam Technology Inc. LANDLEX S400X 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 16, 2005

#### Device

Trade name: LANDLEX S400X 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: Cycling and Health Tech Industry R&D Center/CHC Name: Bewell SC 20 k number: K043326 Date cleared: 01/26/2005

#### Intend use of device

LANDLEX S400X 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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K050793

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#### Device description:

The LANDLEX S400X 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 S400X 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, automatic headlight 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 9 km/hr (5.6 mph).

#### Substantial equivalence:

The LANDLEX S400X scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.

Analysis of comparison of design, function and feature of LANDLEX S400X scooter to CHC Bewell SC 20 (K043326), 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 S400X scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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K050793

#### Non-Clinical testing

LANDLEX S400X 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IUL 7 - 2005

Mr. Chang Wan-Lan Cycling and Health Tech. Industry R & D Center Number 17, 37th Road Taichung Industry Park Taichung, China (Taiwan) 40768

Re: K050793

Trade/Device Name: Landlex S400X Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: June 9, 2005 Received: June 9, 2005

Dear Mr. Wan-Lan:

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. Chang Wan-Lan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office 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 Manufacturers, International 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 vours.

Stupt Clurda

Mirian 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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To: Elmar Einberg

Subject: K 050793

+0021-301-594-2358

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

## Statement of Indications for Use

510(k) Number (if known): K050793

Device Name: LANDLEX S400X

Indications for Use:

The LANDLEX S400X 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.

Prescription Use Over-The-Counter Use _ X (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) AND/OR (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Stut Plurde
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

K050793 510(k) Number_ (Posted November 13, 2003)

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