SCOUT BOSS

K023961 · Burke, Inc. · ITI · Dec 24, 2002 · Physical Medicine

Device Facts

• Record ID: K023961
• Device Name: SCOUT BOSS
• Applicant: Burke, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Dec 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals.

Device Story

Scout Boss is a motorized, battery-powered wheelchair designed for indoor and outdoor mobility. It is intended for use by larger disabled individuals to facilitate independent movement. The device operates via standard electric wheelchair controls, allowing the user to navigate various environments. It serves as a mobility aid, enhancing the patient's ability to perform daily activities and improving overall quality of life.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and regulatory classification.

Technological Characteristics

Motorized, battery-powered wheelchair; Class II device (21 CFR 890.3860); product code ITI. Designed for larger individuals.

Indications for Use

Indicated for larger disabled individuals requiring indoor/outdoor mobility assistance via a motorized, battery-powered wheelchair.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of an eagle with three lines representing its wings and a wavy line representing its body.

Public Health Service

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

DEC 24 2002

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

Re: K023961

Trade/Device Name: Scout Boss Regulation Number: 890.3860 Regulation Name: Wheelchair, powered Regulatory Class: Class.II Product Code: ITI Dated: December 9, 2002 Received: December 9, 2002

Dear Mr. Kramer:

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 is 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

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Page 2 - Mr. Du Wayne E. Kramer, Jr.

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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]. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Wley Witte

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023961/S1

BURKE INC. RE: SCOUT BOSS 510(k) submission K023961

Indication for Use: The SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals. : 上海

Bu Wayne E. Turner/r

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)

Ulla Witt

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Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use ✓

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