SUNPEX TECHNOLOGIES MODEL SE 01

K021925 · Sunpex Technology Co., Ltd. · INI · Nov 8, 2002 · Physical Medicine

Device Facts

• Record ID: K021925
• Device Name: SUNPEX TECHNOLOGIES MODEL SE 01
• Applicant: Sunpex Technology Co., Ltd.
• Product Code: INI · Physical Medicine
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3800
• Device Class: Class 2

Intended Use

The intended use of the Model SE 01 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 01 is a four-wheel electric scooter designed to provide mobility for adults. Device operates via simple hand controls, allowing user to navigate independently. Intended for use by individuals capable of sitting on the scooter without assistance. Provides mobility support in various environments; enhances patient independence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Four-wheel electric scooter; motorized propulsion; hand-controlled operation; Class II device (Product Code: INI).

Indications for Use

Indicated for adults requiring mobility assistance who possess the physical capacity to sit independently and operate hand-based 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 8 2002

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

Re: K021925

Trade/Device Name: Sunpex Technologies Model SE 01, Four Wheel Electric Scooter Regulation Number: 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: August 12, 2002 Received: August 15, 2002

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 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 - Mr. Leonard Frier

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 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" (21 CFR 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.

sincerely yours,

Mark N. Melkerson

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 SE 01, Four Wheel Electric Scooter

The intended use of the Model SE 01 is to provide mobility to adults with Indications For Use: 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)

Mark A. Millherson

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

510(k) Number_

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Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use ^