BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED

K041025 · Golden Technologies, Inc. · INI · May 3, 2004 · Physical Medicine

Device Facts

• Record ID: K041025
• Device Name: BUZZAROUND, VEHICLE, MOTORIZED 3-WHEELED
• Applicant: Golden Technologies, Inc.
• Product Code: INI · Physical Medicine
• Decision Date: May 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.3800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Buzzaround is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.

Device Story

Buzzaround is a 3-wheeled, battery-powered mobility scooter; intended for individuals with limited mobility who can operate hand controls. Device features welded steel frame; separable front/rear sections for transport; 24-volt battery pack; 70-amp controller; electric motor with gear housing. User operates via paddle-type potentiometer; intelligent electronic regenerative braking and disc parking brake included. Provides mobility in various settings; weight capacity 300 lbs; max speed 4.5 mph; range 10-15 miles. Benefits include increased independence for mobility-impaired users.

Clinical Evidence

No clinical data.

Technological Characteristics

Welded steel frame; 24-volt battery; 70-amp controller; paddle-type potentiometer control; regenerative and disc braking. Meets California Bulletin 117 fire standards for seating. Tested per ANSI/RESNA WC/01, WC/02, WC/03, WC/05, WC/10, and WC/Vol. 2-1998.

Indications for Use

Indicated for persons limited to a seated position capable of operating a simple hand control who require a lightweight mobility scooter.

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.

Predicate Devices

• Companion 221 (K012258)

Submission Summary (Full Text)

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K041025
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Exhibit 3

# MAY = 3 2004

## 510 (K) Summary Golden Technologies, Inc. 510 (K) Premarket Notification Buzzaround

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Golden Technologies, Inc. 401 Bridge Street Old Forge, Pa. 18518 Phone: [phone] Facsimile: [phone] Contact Person: Gene Kulon Official Correspondent Date Prepared: March 18, 2004

Name of Device and Name / Address of Sponsor:

Buzzaround

Golden Technologies, Inc. 401 Bridge Street Old Forge, Pa. 18518 Phone: [phone] Facsimile: [phone]

Common or Usual Name: 3-Wheeled scootcr

Classification Name: Motorized Three-Wheel Vehicle

Comparison to Predicate Devices:

The product, which is substantially equivalent to the Buzzaround, is the Companion 221, (K012258). They are both controlled by the use of a paddle type potentiomctcr, with onboard batteries and battery charger. All safety features are equivalent.

Device Description:

The Buzzaround is a three wheeled battery powered scooter. It has a 70-amp controller, which is used to operate the Buzzaround. The two-piece base of the scooter is made of welded steel construction. The drive unit is separable from the floor pan and includes spaced apart, differentially connected rear wheels (2) and an electric motor with a gear housing. It comes standard with a removable fold down scat, which is connected, to the drive unit frame via a pedestal and seat post concentrating the users weight over the rear wheels to aid in traction. All

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K041025
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seating meets California Bulletin 117 fire standards. The Buzzaround comes standard with a compact removable 24-volt battery pack and on or off board charger and has an operating range of 10 to 15 miles on a full charge. The front and rear frames can be separated for stowage and transportation. It has intelligent electronic regenerative braking and a disc parking brake. The weight capacity is 300-lbs and it has a maximum speed of 4.5-mph

### Intended Use:

The intended use of the Buzzaround is to provide mobility to persons limited to a seated position that are capable of operating an electric scooter.

Discussion of non-clinical tests performed for determinations of substantial equivalence are as follows:

ANSI/RESNA WC/01 1990 Determination of Static Stability Testing ANSI/RESNA WC/02 1991 Determination of Dynamic Stability Testing ANSI/RESNA WC/03 1990 Determination of the Effectiveness of brakes ANSI/RESNA WC/05 1990 Determination of overall Dimensions, Mass, and Turning Space ANSI/RESNA WC/10 1990 Determination of Obstacle Climbing Ability ANSI/RESNA WC/Vol. 2-1998 Requirements and Test Methods for Electromagnetic Compatibility of Electric Powered Wheelchairs and Scooters.

Discussion of Clinical Tests Performed:

N/A

Conclusions:

The Buzzaround has the same intended use and similar technological characteristics as the Companion 221. Moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Buzzaround device is substantially equivalent to the predicate device.

Discussion of Clinical Tests Performed:

N/A

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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 3 2004

Gene R. Kulon Golden Technologies, Inc. 401 Bridge Street Old Forge, Pennsylvania 18518

Re: K041025

Trade/Device Name: Buzzaround, Vehicle, Motorized 3-Wheeled Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 15, 2004 Received: April 21, 2004

Dear Mr. Kulon:

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, I sting 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's issuance of a substantial equivalence determination does not mcan 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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Gene R. Kulon

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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milherson

Cclia 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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## EXHIBIT 2

:

Page _ 1 of

# 510(k) Number (if known): K-

Device Name: Buzzaround, Vehicle, Motorized 3-Wheeled

### Indications for Use:

The intended use of the Buzzaround is to provide a lightweight scooter that offers mobility to persons limited to a seated position who are capable of overating a simple hand control.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use
OR
(Optional Format 1-2-96)

Division of General, Restorative, and Neurological Devices

Number K04/025