STREET

K032765 · Permobil AB · ITI · Jan 30, 2004 · Physical Medicine

Device Facts

• Record ID: K032765
• Device Name: STREET
• Applicant: Permobil AB
• Product Code: ITI · Physical Medicine
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the STREET powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

Device Story

STREET is a battery-powered, rear-wheel-drive wheelchair; frame constructed of welded steel. Input provided by user via joystick interface; joystick signals PG power wheelchair PM100Amp controller. Controller manages motor, gear, and brake units. Actuating joystick releases solenoid electromechanical brakes, allowing movement; releasing joystick slows chair to stop and automatically re-engages brakes. Powered by two 12VDC 73Ah batteries; driving range up to 35 km. Used in indoor and outdoor environments by patients with mobility limitations. Healthcare providers use device to restore mobility; patient operates device independently via joystick.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Welded steel frame; rear-wheel drive; two 12VDC 73Ah batteries; PG power wheelchair PM100Amp controller; solenoid electromechanical braking system; joystick user interface.

Indications for Use

Indicated for persons limited to a seated position requiring indoor and outdoor mobility assistance; must be capable of operating a 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.

Predicate Devices

• Quantum Blast (K011993)

Submission Summary (Full Text)

{0}------------------------------------------------

K032765

# ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: STREET

# JAN : 0 2004

## Attachment 12

# 510(k) Summary

| Submitter | Permobil AB<br>Box 120<br>Årvältsvägen 10<br>S-861 23 Timrå<br>Sweden |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Bengt Persson |
| e-mail address: | [e-mail] |
| Date Prepared: | September 1, 2003 |
| Device name: | STREET |
| Classification Name: | Powered wheelchair |
| Predicate Devices: | Quantum Blast (K011993) manufactured by Pride Mobility. |
| Intended use: | The intended use of the STREET powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. |
| Description of device: | Street Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair PM100Amp controller. The user interface is a joystick. The Street is powered by two 12VDC 73Ah, Group 24 batteries, approximate driving range on fully charged batteries is up to 35 km (22 miles), depending on use and the terrain the chair is driven on. The chair frame is of welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 2004

Mr. Bengt Persson Director, Quality and Environment Permobil AB Box 120 Årvältsvägen 10 S-861 23 Timrå Sweden

Re: K032765

Trade/Device Name: STREET Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: December 2, 2003 Received: December 2, 2003

Dear Mr. Persson:

We have reviewed your Scction 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 Fedcral 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither 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 I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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.

{2}------------------------------------------------

Page 2 – Mr. Bengt Persson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter with and in you vo or substantial equivalence of your device to a legally premativer notification." The 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 if you desire specific as no as a moliance at [phone]. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Sincerely yours,

Mark N. Millikan

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

{3}------------------------------------------------

# ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: STREET

Image /page/3/Picture/1 description: The image shows a black oval with the word "permbil" written in white letters inside. The letters are stylized and have a rounded appearance. The oval is surrounded by a thin white border.

Attachment 13

### Indication for Use Statement

#### Substantial Equivalence

The product, which is substantially equivalent to this device, is Pride Mobility's Quantum Blast Rear Wheel Drive Power Wheclchair (K011993 July 13, 2000).

### Safety and effectiveness

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

#### Indication for Use

The intended use is to provide indoor and outdoor mobility to persons restricted to a sitting position.

#### 510(k) number

Not assigned at the writing of this submission

#### Device name

STREET

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (per 21 CFR 801.109) □

or

Over the counter use

f Mark N Milkum
(SID)
neral, Restorative

Y
[e]'

I Devices

-

KO32

(Division Sign-Off) Division of General Restorative Devices

510(k) number