SUNPEX TECHNOLOGIES MODEL SE03

K033019 · Sunpex Technology Co., Ltd. · INI · Jan 22, 2004 · Physical Medicine

Device Facts

• Record ID: K033019
• Device Name: SUNPEX TECHNOLOGIES MODEL SE03
• Applicant: Sunpex Technology Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Jan 22, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Model SE03 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

Electric powered scooter (Model SE03) provides mobility for adults; operated via simple hand controls. User must be capable of independent sitting. Device functions as motorized three-wheeled vehicle; intended for personal transport. Clinical benefit includes restored mobility for individuals with physical limitations. Used in various environments; operated by the patient.

Technological Characteristics

Motorized three-wheeled vehicle; electric powered; hand-controlled operation. Class II device under 21 CFR 890.3800.

Indications for Use

Indicated for adults requiring mobility assistance who possess the physical capacity to sit independently and operate a hand-controlled motorized vehicle.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 2004

Sunpex Technology Company. I.TD. Leonard Frier c/o Met Laboratories, Inc. 914 West Patapsco Avenue Baltimore, Maryland 21230

Re: K033019

Trade/Device Name: Electric Powered Scooter, Model SE03 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-whecled vehicle Regulatory Class: II Product Code: INI Dated: December 26, 2003 Received: December 29. 2003

Dear Mr. Frier:

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 adultcration.

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 I`DA'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.

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Page 2 – Mr. Leonard Frier

This letter will allow you to begin marketing your device as described in your Section 510/km 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/dsma/dsmamain.html

Sincerely yours.

sincerely yours.

Mark N. Millherson

Celia M. 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

510K number:

Device Name: Model SE03, Electric Power Scooter ·

Indications For Use: The intended use of the Model SE03 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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