THE BRUNO POWERBASE, MODEL PSB-2200

K991954 · Bruno Independent Living Aids, Inc. · ITI · Nov 2, 1999 · Physical Medicine

Device Facts

• Record ID: K991954
• Device Name: THE BRUNO POWERBASE, MODEL PSB-2200
• Applicant: Bruno Independent Living Aids, Inc.
• Product Code: ITI · Physical Medicine
• Decision Date: Nov 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Bruno Powerbase Model 2200 is designed to assist those Homecare Patients whose afflictions or disabilities require them to use motorized assistance for daily mobility. Typically these users would not be able to maintain independence with a manual wheelchair. The Bruno Powerbase is intended to be used in a primarily indoor environments with limited use on hard relatively level outdoor surfaces such as sidewalks, ramps and hard packed garden plots.

Device Story

Power wheelchair for homecare patients; provides motorized mobility assistance for individuals unable to operate manual wheelchairs. Used primarily in indoor environments; limited use on hard, level outdoor surfaces (sidewalks, ramps, hard-packed garden plots). Operated by the patient. Device facilitates daily mobility and independence.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Motorized power wheelchair; intended for indoor and limited outdoor use on level surfaces. Class II device (Product Code ITI).

Indications for Use

Indicated for homecare patients with afflictions or disabilities requiring motorized assistance for daily mobility who are unable to maintain independence with a manual 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov - 2 1999

Mr. William W. Belson III Director of Engineering Bruno Independent Living Aids, Inc. 1780 Executive Drive Oconomoc, Wisconsin 53066

Re: K991954 The Bruno Powerbase, Model PSB-2200 Trade Name: Requlatory Class: II Product Code: ITI Dated: September 20, 1999 Received: September 21, 1999

Dear Mr. Belson:

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 The general controls provisions of the Act of the Act. include reguirements 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 In addition, FDA may publish further announcements action. 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. William W. Belson III

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.qov/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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Image /page/2/Picture/0 description: The image shows the logo for Bruno Independent Living Aids. The logo features a stylized image to the left of the word "BRUNO" in large, bold letters. Below "BRUNO" is the text "INDEPENDENT LIVING AIDS" in a smaller font. Underneath that, it says "ISO 9001 CERTIFIED".

## FDA 510(k) INDICATIONS FOR USE

510(k) Number: Device Name:

K991954 Power Wheelchair Model 2200

Indications For Use:

The Bruno Powerbase Model 2200 is designed to assist those Homecare Patients whose afflictions or disabilities require them to use motorized assistance for daily mobility. Typically these users would not be able to maintain independence with a manual wheelchair.

The Bruno Powerbase is intended to be used in a primarily indoor environments with limited use on hard relatively level outdoor surfaces such as sidewalks, ramps and hard packed garden plots.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Division of General Restorative Devices |

510(k) Number .

Prescription Use (PER 21 CFR 801.109) OR

Over-The-Counter Use X

(Optional format 1-2-96)

510(k) K991954 Response letter