SUNSPEX TECHNOLOGIES MODEL SE 02

K021371 · Sunpex Technology Co., Ltd. · INI · May 16, 2002 · Physical Medicine

Device Facts

• Record ID: K021371
• Device Name: SUNSPEX TECHNOLOGIES MODEL SE 02
• Applicant: Sunpex Technology Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: May 16, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Model SE 02 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

Device Story

Model SE 02 is a three-wheeled electric scooter designed to provide mobility assistance. Device operates via simple hand controls; user must be capable of sitting independently. Intended for use by adults with mobility limitations. Device provides powered transportation; enhances patient independence. No complex software or automated processing involved.

Technological Characteristics

Three-wheeled electric scooter; powered mobility device; hand-controlled operation.

Indications for Use

Indicated for adults with mobility impairments who are capable of sitting independently and operating hand controls.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

MAY 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Judy Hsu Sales Manager Sunpex Technology, Company, Ltd. 676 Chung Hsiao Road Chia Yi City, Taiwan

Re: K021371

Trade/Device Name: Model SE 02, Three Wheel Electric Scooter Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 30, 2002 Received: April 30, 2002

Dear Ms. Hsu:

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. Judy Hsu :

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 prarketed 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Muriam C. Provost

for Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## KOZI371 510K number:

Device Name: Model SE 02, Three Wheel Electric Scooter

Indications For Use: The intended use of the Model SE 02 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number_KO21371

Prescription Use

Over-The-Counter Use_