PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)

K965123 · Burke, Inc. · INI · Jul 17, 1997 · Physical Medicine

Device Facts

• Record ID: K965123
• Device Name: PACE SAVER, LITTLE JUNIOR (MODIFICATION)(MOTORIZED THREE-WHEELED VEHICLE)
• Applicant: Burke, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: Jul 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Motorized three-wheeled and four-wheeled battery powered scooters are intended for medical purposes by disabled persons and other non-medical purposes.

Device Story

Battery-powered, three- or four-wheeled motorized scooter; provides mobility assistance for disabled individuals. Operated by user via manual controls; facilitates independent navigation in various environments. Benefits include improved mobility and accessibility for users with physical impairments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered motorized scooter; three- or four-wheeled configuration. Class II device (Product Code: INI).

Indications for Use

Indicated for disabled persons 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.

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

DuWayne E. Kramer, Jr.
*President
Burke, Inc.
1800 Merriam Lane
Kansas City, Kansas 66106

JUL 17 1997

Re: K965123
PaceSaver Espree Scooter
Regulatory Class: II
Product Code: INI
Dated: June 11, 1997
Received: June 16, 1997

Dear Mr. Kramer:

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 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 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 - DuWayne E. Kramer, Jr.

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,


Enclosure

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K 965123

# INTENDED USE

Motorized three-wheeled and four-wheeled battery powered scooters are intended for medical purposes by disabled persons and other non-medical purposes.


Over-the-Counter Use