LANDLEX, MODEL S403X

K063196 · Besteam Technology, Inc. · INI · Jan 23, 2007 · Physical Medicine

Device Facts

• Record ID: K063196
• Device Name: LANDLEX, MODEL S403X
• Applicant: Besteam Technology, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Jan 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The LANDLEX S403X 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

LANDLEX S403X is a battery-operated, motorized three-wheeled scooter for indoor/outdoor transportation. Operated by the user via a tiller handle and thumb-operated potentiometer throttle control lever to manage forward and reverse motion. Provides mobility for disabled or elderly individuals restricted to a seated position. No complex software, AI, or remote processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-operated motorized three-wheeled vehicle. Controlled via tiller handle and thumb-operated potentiometer throttle. Class II device (21 CFR 890.3800).

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

• LANDLEX S400X (K050793)

Submission Summary (Full Text)

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K06 3196

JAN 2 3 2007

Appendix

# Besteam Technology Inc.

No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan

Fax: [phone] Phone: [phone]

# 510(k) Summary

## Device

Trade name: LANDLEX S403X

Common (generic) name: Electrical scooter

Classification name: Motorized three-wheeled vehicle

Medical specialty (Panel): Physical Medicine Device

Regulation number: 890.3800

Product Code: INI

Classification: Class II

Predicate devices

LANDLEX S400X (K050793) / Besteam Technology Inc.

Intend use of device

LANDLEX S403X scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

#### Device description:

The LANDLEX S403X scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

### Substantial equivalence:

The LANDLEX S403X scooter is substantially equivalent to the LANDLEX S400X (K050793) manufactured by Besteam.

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 S403X scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Besteam Technology, Inc. % Ms. Junnata Chang 14F-2 No. 1 Lane 25 Zhuangjing Road Banqiao, China (Taiwan) 220

JAN 2 3 2007

Re: K063196

:

Trade/Device Name: Landlex S403X Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: December 21, 2006 Received: December 21, 2006

Dear Ms. Chang:

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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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 your

J. Mullen

Mark N. Melkerson 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): _ K063196

Device Name: LANDLEX S403X

Indications for Use:

The LANDLEX S403X 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 | |
|-----------------------------|--------|
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over-The-Counter Use | X |
| (Part 21 CFR 807 Subpart C) | |

(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

Roh

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** 11063196

(Posted November 13, 2003)