AVANTICARE, MODEL SA4022

K051538 · Lerado China Limited · INI · Jul 21, 2005 · Physical Medicine

Device Facts

• Record ID: K051538
• Device Name: AVANTICARE, MODEL SA4022
• Applicant: Lerado China Limited
• Product Code: INI · Physical Medicine
• Decision Date: Jul 21, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The AVANTICARE SA4022 scoter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated po lition.

Device Story

Battery-operated motorized three-wheeled scooter; provides indoor/outdoor transportation for disabled or elderly users. Operated via tiller handle and thumb-actuated potentiometer throttle control for forward/reverse motion. Device serves as mobility aid; enables independent navigation for users with limited mobility. No complex software or automated processing involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Motorized three-wheeled vehicle; battery-operated; tiller handle steering; thumb-operated potentiometer throttle control. Class II device per 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

• Bewell SC 20 (K043326)

Submission Summary (Full Text)

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JUL 2 1 2005

K05/538

Image /page/0/Picture/3 description: The image shows a logo with the word "LERADO" in large, bold letters. A triangular shape is placed between the letters "R" and "D", resembling a mountain. Below the main word, the word "LERADO" is repeated in smaller letters, followed by the word "GROUP".

No.22, Kuang Fu Rd., Chia Tài Industrial Park, Tai Pao City, Chia Yì Hien, Tàirrache com [phone] website: http://www.lerado.com/ TEL: [phone]

# 510(k) Summary

### Device

Trade name: AVANTICARE SA4022 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

Bewell SC 20 (K043326)/Cycling and Health Tech Industry R&D Center/CHC Intend use of device

AVANTICARE SA4022 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

#### Device description:

The AVANTICARE SA4022 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 AVANTICARE SA4022 scooter is substantially equivalent to the Bewell SC 20 (K043326) manufactured by Cycling and Health Tech Industry R&D Center/CHC.

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, LERADO CHINA LIMITED believes that the AVANTICARE SA4022 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 United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2005

Mr. Jeff Chang Lerado China Limited 16 F.-2, No. 462, Sec. 2 Chongde Rd., Beitun District Taichung, China (Taiwan) 40653

Re: K051538

Trade/Device Name: AVANTICARE SA4022 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: May 12, 2005 Received: June 10, 2005

Dear Mr. Jeff Chang:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because the device is substantially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the cacrosure) to regars managers of the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire in assee approval of a premarket approval application (PMA). alle Costlictic Act (71ct) that to not required to the general controls provisions of the Act. The I ou may, mercere, maniel the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 (soc aborto) in existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease of advised that I Dri 3 issualled or our device complies with other requirements of the Act that I DA has made a acternations administered by other Federal agencies. You must of any I catal surdles and regulations sincluding, but not limited to: registration and listing (21 comply with an the 110 110 Part 801); good manufacturing practice requirements as set CFR in the quality systems (21 CFR Part 820); and if applicable, the electronic forth in the quart) byevelle (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Jeff Chang

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maing of substantial equivalence of your device to a legally premails. The first in the Brice 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 IT you ucate specific adrive for your accell 276-0120. Also, please note the regulation entitled, Connact the Office of Compulser in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miormation of your resumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Eichhorn

Miriam 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 AVANTICARE SA4 122

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Indications for Use

The AVANTICARE SA4022 scoter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated po lition.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use -(Part 21 CFR 801 Subpart D) A. VD/OR (Part 21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELO'V THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Euh

Jision Sign-Off) vision of General, Restorative ad Neurological Devices

Number KOSIS38

(Posted November 13, 2003)

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