SOLO

K970523 · Ranger All Season Corp. · INI · Jun 3, 1997 · Physical Medicine

Device Facts

• Record ID: K970523
• Device Name: SOLO
• Applicant: Ranger All Season Corp.
• Product Code: INI · Physical Medicine
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Provides mobility for the disabled

Device Story

Solo scooter; provides mobility for disabled users. Operated by patient; intended for over-the-counter use. Device functions as personal mobility aid; assists users with physical limitations in navigating environments. Output is physical transport of user. Benefits include increased independence and mobility for individuals with disabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mobility scooter; form factor designed for personal transport. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for disabled individuals requiring assistance with mobility.

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.

Reference Devices

• SAFARI scooter

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Ronald Stewart
Director of Engineering
Ranger All Season Corporation
P.O. Box 132
George, Iowa 51237

Re: K970523
Solo
Regulatory Class: II
Product Code: INI
Dated: April 1, 1997
Received: April 4, 1997

Dear Mr. Stewart:

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 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 (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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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. Ronald Stewart

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

Enclosure

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# INTENDED USE

The intended use of the SOLO and the SAFARI scooters is:

"Provides mobility for the disabled".


Over-the-Counter Use ☑

RANGER ALL-SEASON CORP.
4/2/97