ELECTRO

K041219 · Permobil AB · ITI · Aug 4, 2004 · Physical Medicine

Device Facts

• Record ID: K041219
• Device Name: ELECTRO
• Applicant: Permobil AB
• Product Code: ITI · Physical Medicine
• Decision Date: Aug 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the ELECTRO 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

Electro is a battery-powered, front-wheel-drive powered wheelchair; controlled by PG VSI 70 amp controller via joystick interface. Frame consists of riveted and welded steel. Powered by two 12VDC 60Ah Group M34 batteries; driving range up to 25 km. Joystick input signals controller to release solenoid electromechanical brakes; chair moves in direction of joystick actuation. Releasing joystick slows chair to stop and automatically re-engages brakes. Used by patients with limited mobility; operated by patient. Provides indoor/outdoor mobility; enhances patient independence.

Clinical Evidence

Bench testing only. Performance data demonstrated the device functioned as intended and was as safe and effective as the predicate device.

Technological Characteristics

Riveted and welded steel frame; front-wheel motor drive; solenoid electromechanical brakes. Powered by two 12VDC 60Ah Group M34 batteries. PG VSI 70 amp controller. Joystick user interface. Indoor/outdoor mobility.

Indications for Use

Indicated for persons limited to a seated position who are capable of operating a powered wheelchair, for indoor and outdoor mobility.

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

• Chairman 2k (1280) (K991658)

Submission Summary (Full Text)

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# ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHÁIR: ELECTRO

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# AUG - 4 2004

Attachment 11

### 510(k) Summary

| Submitter | Permobil AB<br>Box 120<br>S-861 23 Timrå<br>Sweden |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Jan Åström |
| e-mail address: | [e-mail] |
| Date Prepared: | April 29, 2004 |
| Device name: | ELECTRO |
| Classification Name: | Powered wheelchair |
| Predicate Devices: | Chairman 2k (1280) (K991658) manufactured by Permobil AB. |
| Intended use: | The intended use of the ELECTRO powered wheelchair is to provide<br>outdoor and indoor mobility to persons limited to a seated position that are<br>capable of operating a powered wheelchair. |
| Description of device: | Electro Powered Wheelchair is battery powered, front wheel motor driven<br>and is controlled by the PG power wheelchair VSI 70 amp controller.<br>The user interface is a joystick.<br>The Electro is powered by two 12VDC 60Ah, Group M34 batteries,<br>approximate driving range on fully charged batteries is up to 25 km (16<br>miles), depending on use and the terrain the chair is driven on.<br>The chair frame is a rived nut and welded steel construction and includes<br>two front drive wheels with drive units (motor, gear, brake), batteries and<br>back pivoting casters.<br>Depending on users needs, the joystick motor control is mounted to the left<br>or right armrest.<br>When the user activates the joystick, the controller receives a signal to<br>release the brakes.<br>With the brakes released, the chair is allowed to move in the direction the<br>joystick is actuated.<br>When the user releases the joystick, the chair slows to a stop and the brakes<br>are automatically re-engaged. The solenoid electromechanical brakes allow<br>the user stop by letting go of the joystick. |

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

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#### Performance Data

In all instances, the Electro functioned as intended.

#### Substantial Equivalence

The Electro is substantially equivalent to the Chairman 2K (#K991658). The File Electro has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Electro is as safe and effective as the Chairman 2K. Thus, the Electro is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2004

Mr. Jan Astrom Quality Engineer Permobil AB Box 120 S-861 23 Timra Sweden

Re: K041219 Trade/Device Name: Electro Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 24, 2004 Received: May 28, 2004

Dear Mr. Astrom:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 31 (x), pecies is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regars the Medical Device Amendments, or to commerce prox to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices mat have occh receitsomed in assee approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not require to the general controls provisions of the Act. The You may, therefore, thanket the devices, books requirements for annual registration, listing of gencial controls provisions of ractice, 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 If your device is classified (600 world) als. Existing major regulations affecting your device can thay be subject to suell additional controller Listing of the 21, Parts 800 to 898. In addition, FDA may be found in the Our neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dr I S issuants over device complies with other requirements of the Act that I DA has made a doter regulations administered by other Federal agencies. You must of any i cacal statutes and regarants, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Jan Astrom

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough manieing of substantial equivalence of your device to a legally prematics notification: The PDF intelligestion 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 acries is. J 301) 594-4659. Also, please note the regulation entitled, Contact the Oriece of Compunited in (21CFR Part 807.97). You may obtain Misolanung of reference to premainters in 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.

Mih. A. Millers

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

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Attachment 12

### INDICATION FOR USE

510(k) number K041219

Device name: Electro

#### Indication for Use

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

Prescription use (Part 21 CFR 801 Subpart D)

or

Over the counter use (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mud. N. Millkin

Division of General, Restorative, and Neurological Devices

510(k) Number K041219