AMIGO MODEL 590000

K983987 · Amigo Mobility Intl., Inc. · INI · Jun 8, 1999 · Physical Medicine

Device Facts

• Record ID: K983987
• Device Name: AMIGO MODEL 590000
• Applicant: Amigo Mobility Intl., Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Jun 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.

Device Story

Amigo Model 590000 is a powered mobility device (scooter) operated via joystick. Designed for personal transportation of individuals with walking impairments. User controls speed and direction through joystick interface. Device provides mobility assistance in various environments. Intended for use by individuals with limited ambulatory capacity to improve independence and mobility.

Technological Characteristics

Powered mobility device; joystick-controlled; Class II; Product Code INI.

Indications for Use

Indicated for walking impaired individuals requiring personal transportation.

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 Druq Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 1999

Mr. Dale Confer Product Design Development Manager Amigo Mobility International, Inc. 6693 Dixie Highway Bridgeport, Michigan 48722-0402

Re: K983987 Amigo Model 590000 Trade Name: Regulatory Class: II Product Code: INI April 23, 1999 Dated: April 26, 1999 Received:

Dear Mr. Confer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Dale Confer

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) NUMBER (IF KNOWN): K

3A1-1

1.95% 11.2% 26.0% 3.0% 1.0% 1.0% 1.0% 1.0% 1.0% 1.4%

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AMIGO MODEL 590000 (Joystick) DEVICE NAME:

INDICATIONS FOR USE:

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.

The subject device and the predicate device intended use, e is personal transportation for walking impaired individuals.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

510(k) Number