MODEL SEGAEGO 4D SCOOTER

K071282 · Dalton Medical Corp. · INI · Jul 27, 2007 · Physical Medicine

Device Facts

• Record ID: K071282
• Device Name: MODEL SEGAEGO 4D SCOOTER
• Applicant: Dalton Medical Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Jul 27, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Segaego 4D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.

Device Story

Scooter Segaego 4D is a motorized three-wheeled vehicle designed to provide mobility for individuals with limited physical capacity. Device operates via user-controlled inputs to navigate environments. Intended for use by patients capable of operating a powered scooter; suitable for over-the-counter use. Provides independent mobility for users limited to a seated position.

Technological Characteristics

Motorized three-wheeled vehicle; Class II device; Product Code INI; 21 CFR 890.3800.

Indications for Use

Indicated for individuals with limited mobility who are capable of operating a powered scooter while in a seated position.

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

Dalton Medical Corporation % Mr. Will Ridgway Sales Manager 1103 Venture Court Carrollton, Texas 75006

JUL 27 2007

Re: K071282 Trade/Device Name: Scooter Segaego 4D Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: June 13, 2007 Received: June 13, 2007

Dear Mr. Ridgway:

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. Will Ridgway

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millan

Mark N. Melkerson 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

510(k) Number (if known):

Segaego 4D Device Name:

Indications For Use:

The intended use of the Segaego 4D is to provide mobility to persons limited to a seated position that are capable of operating a powered scooter.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

XX Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of in vitro Diagnostic Devices (OIVD)

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

510(k) Number K071282 Page 1 of ***_***