RUIKE, MODEL 3411

K062646 · Shanghai Ruike Sports Goods Co., Ltd. · INI · Feb 5, 2007 · Physical Medicine

Device Facts

• Record ID: K062646
• Device Name: RUIKE, MODEL 3411
• Applicant: Shanghai Ruike Sports Goods Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Feb 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Indications for Use

Ruike 3411 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

Device Story

The Ruike 3411 is a battery-operated, motorized three-wheeled scooter designed for indoor and outdoor transportation. It is operated by the user via a tiller handle and a thumb-operated potentiometer throttle control lever, which engages and disengages motion in both forward and reverse directions. The device provides mobility for disabled or elderly individuals who are restricted to a seated position. It functions as a personal transport vehicle, allowing users to navigate their environment independently.

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. Indoor/outdoor form factor.

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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K062646

# Shanghai Ruike Sports Goods CO., LTD.

No. 689, Xinhu Road, Shanghai, China TEL: [phone] FAX: [phone]

### 510(k) Summary

#### Device

FEB - 5 2007

Trade name: Ruike 3411 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

LANDLEX S400X (K 050793)/ Besteam Technology Inc.

#### Intend use of device

Ruike 3411 scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position.

### Device description:

The Ruike 3411 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 Ruike 3411 scooter is substantially equivalent to the LANDLEX S400X (K050793) manufactured by Besteam Technology Inc.,

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 perfaining to safety or effectiveness. Therefore, Shanghai Ruike Sports Goods CO., LTD. believes that the Ruike 3411 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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanhai Ruike Sports Goods Co., Ltd. % Ms. Junnata Chang 14F-2, No. 1, Lane 25 Zhuangjing Road Banqio, Taipei County China (Taiwan) 220

FEB - 5 2007

Re: K062646

Trade/Device Name: Ruike 3411 Scotter Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: September 1, 2006 Received: September 4, 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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Page 2 - Ms. Junnata Chang

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 yours,

for
Mark N. Melkerson

Mark N. M 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): _k062646

Device Name: Ruike 3411

Indications for Use:

The Ruike 3411 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) Page 1 of 1

V.L.R

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

510(k) Numb 3-1

(Posted November 13, 2003)