LANDLEX, MODEL P100X

K060042 · Besteam Technology, Inc. · INI · Feb 14, 2006 · Physical Medicine

Device Facts

• Record ID: K060042
• Device Name: LANDLEX, MODEL P100X
• Applicant: Besteam Technology, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Feb 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The LANDLEX P100X 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 P100X 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. Designed for disabled or elderly individuals with limited mobility who require a seated position. Device provides independent mobility; user controls speed and direction directly. No complex software or automated algorithms involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-operated motorized three-wheeled vehicle. Tiller handle steering with thumb-operated potentiometer throttle control. Class II medical 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 S300X (K050792)
• Proasia L3402 (K052378)

Submission Summary (Full Text)

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FEB 1 4 2006

Ko60042

# 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 P100X

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 S300X (K050792) / Besteam Technology Inc.

Proasia L3402 (K052378) / Proasia

#### Intend use of device

LANDLEX P100X 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 P100X 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 P100X scooter is substantially equivalent to the LANDLEX S300X (K050792) and Proasia L3402 (K052378) manufactured by Besteam and Proasia, respectively.

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 P100X scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2006

Mr. Jack Chen Besteam Technology Inc. No.16-1, Ziqiang 1st Rd., Zhongli City, Taoyuan Hsien, Taiwan, 32063

Re: K060042

Trade/Device Name: LANDLEX P100X Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: January 03, 2006 Received: January 06, 2006

Dear Mr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premainted in substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate for use stated in the enclosure) the actering and as a concess marketed in interstate for use stated in the encrosule) to regally manator date of the Medical Device Ameral Food. Drug commerce prior to May 28, 1776, the enaounce with the provisions of the Federal Food. Drug. devices that have been reclassince in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premisions of the Act, 7 and Costheile Act (Act) that to hot require approvial controls provisions of the Act. The You may, merelove, market the act include requirements for annual registration, listing of general controls provisions of the rest 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 is classified (500 a0070) ins existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous or events concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc advised that I Dri 3 issualles of a complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any it cach stututes and registerients, including, but not limited to: registration and listing (21 comply with an the 11ct 811 Part 801); good manufacturing practice requirements as set CFR Part 807); adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) I mis letter will anow you to ogin manteans your and equivalence of your device to a legally premarket notification. The PDF mailing of casion 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 If you desire specific advice for your ac not one one one one one the regulation entitled, Colliact the Office of Complance as (27,74) = (21CFR Part 807.97). You may obtain Misolanding of Icrerchoe to premantonsibilities under the Act from the Division of Small other general international 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 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 P100X

Indications for Use:

The LANDLEX P100X 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 __X Prescription Use (Part 21 CFR 807 Subpart C) (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

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

510(k) Number K060047

(Posted November 13, 2003)