SCOUT

K982158 · Burke, Inc. · ITI · Aug 31, 1998 · Physical Medicine

Device Facts

• Record ID: K982158
• Device Name: SCOUT
• Applicant: Burke, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 31, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Motorized battery powered wheelchair for mobility purposes by disabled persons.

Device Story

Scout is a motorized, battery-powered wheelchair designed to provide mobility for disabled individuals. Operated by the user via manual controls, the device functions as a personal transport aid. It is intended for use in various environments where the user requires assistance with movement. The device provides independent mobility, allowing users to navigate their surroundings, thereby improving daily functional independence.

Clinical Evidence

No clinical data provided; substantial equivalence based on device description and intended use.

Technological Characteristics

Motorized, battery-powered wheelchair. Class II device (Product Code: ITI).

Indications for Use

Indicated for disabled persons requiring motorized battery-powered mobility assistance.

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 1998

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

K982158 Re: Trade Name: Scout Regulatory Class: II Product Code: ITI Dated: June 17, 1998 Received: June 19, 1998

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. ਬੋ 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 - Mr. 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,

Celia M. Witten, Ph.D., M.

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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510(k) Number: K982158

Device Name: Power Wheelchair

Indication For Use: Motorized battery powered wheelchair for mobility purposes by disabled persons.

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(Division Sign-Off) of General Restorative Devices, 5 I ປ(k) Number ______________________________________________________________________________________________________________________________________________________________ 98215

Over-the-Counter Use

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