AVANTICARE, MODEL SA4021

K060068 · Lerado China Limited · INI · Mar 8, 2006 · Physical Medicine

Device Facts

• Record ID: K060068
• Device Name: AVANTICARE, MODEL SA4021
• Applicant: Lerado China Limited
• Product Code: INI · Physical Medicine
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

AVANTICARE SA4021 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device Story

Battery-operated motorized three-wheeled scooter; provides indoor/outdoor transportation for disabled or elderly users. Operated by user via tiller handle and thumb-actuated potentiometer throttle lever for forward/reverse motion. Device serves as mobility aid for individuals limited to seated position. No complex processing or software involved.

Technological Characteristics

Battery-operated motorized three-wheeled vehicle; tiller-steered; thumb-actuated potentiometer throttle control. Class II device.

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)
• CHC AVANTICARE SA4022 (K051538)

Submission Summary (Full Text)

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K060068

Image /page/0/Picture/1 description: The image shows the logo for Lerado Group. The logo is black and white and includes the text "LERADO" in large, bold letters. Above the logo, the text "MAR 8 2006" is visible. The logo has a triangle in the middle of the word Lerado.

DO CHINA L No.22, Kuang Fu Rd., Chia Tai Industrial Park, Tai Pao City, Chia Yi Hsien, Taiwan TEL: [phone] FAX: [phone] website:http://www.lerado.com/

# 510(k) Summary

#### Device

Trade name: AVANTICARE SA4021 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 AVANTICARE SA4022(K051538)/ LERADO CHINA LIMITED

#### Intend use of device

AVANTICARE SA4021 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 SA4021 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 SA4021 scooter is substantially equivalent to the Bewell SC 20 (K043326) and AVANTICARE SA4022 (K051538) manufactured by Cycling and Health Tech Industry R&D Center/CHC and LERADO CHINA LIMITED.

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 SA4021 scooter is substantially equivalent to legally marketed devices currently in commercial distribution.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 8

Lerado China Limited c/o Mr. Jeff Chang 16 F .- 2, No. 462, Section 2 Chongde Road, Beitun District Taichung, China (Taiwan) 40653

Re: K060068

Trade/Device Name: Avanticare SA4021 Scooter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: January 27, 2006 Received: February 10, 2006

Dear Mr. 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. ITA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs 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. 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

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Page 2 - Mr. Chang

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. "Misbränding 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/dsma/dsmamain.html

Sincerely yours.

Hubert Leunens

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

and the contract and the comments of the comments of the comments of

510(k) Number (if known):

Device Name: AVANTICARE SA4021

Indications for Use:

The AVANTICARE SA4021 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) AND/OR (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

Herbert Leunard

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

10(k) Number K060068

(Posted November 13, 2003)