LEVO COMBI

K030893 · Levo AG · IPL · Apr 2, 2003 · Physical Medicine

Device Facts

• Record ID: K030893
• Device Name: LEVO COMBI
• Applicant: Levo AG
• Product Code: IPL · Physical Medicine
• Decision Date: Apr 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.

Device Story

LEVO combi is a battery-powered, center-wheel-drive electric wheelchair; provides indoor/outdoor mobility; enables transitions between sitting and standing positions; features reclining and seat/back lifting mechanisms. Operated by user via Penny & Giles Pilot+ joystick controller mounted on armrest. Base construction: welded steel; includes two 12V55Ah batteries, two 14" center drive wheels, two 8" front casters, and one 5.5" rear caster with suspension. Device benefits patients by facilitating position changes and improving biomechanical response. Used in various environments for daily mobility.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design experience from the predicate device and technical specifications.

Technological Characteristics

Welded steel base frame; center-wheel drive; two 12V55Ah batteries; Penny & Giles Pilot+ electronic controller; stand-up, lift, and recline actuators. Dimensions: 14" center wheels, 8" front casters, 5.5" rear caster. Connectivity: joystick-based control. Power: battery-driven motors with integrated parking brakes.

Indications for Use

Indicated for individuals requiring a power wheelchair with position-changing capabilities who cannot stand independently, including those with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, or rheumatism.

Regulatory Classification

Identification

A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.

Predicate Devices

• LEVO mobil LCM (K963817)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

K030893

## LEVO combi

APR - 2 2003

| Submitter: | LEVO AG<br>P.O. Box 1272<br>Anglikerstrasse 20<br>CH-5610 Wohlen, Switzerland |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone:<br>Fax: | [phone]<br>[phone] |
| Contact Person: | Mr. Thomas Raeber, Managing Director or<br>Dr. Kurt H. Fischer, CEO |
| E-Mail-Address: | [e-mail]<br>[e-mail] |
| Device Name: | LEVO combi |
| Classification Name: | Electrical Power Wheelchair, Stand-up |
| Identification of<br>Predicate Devices: | LEVO mobil LCM (K 963817) |
| Indtended Use: | The LEVO combi stand-up electrical power wheelchair<br>is a product which changes peoples position not only<br>from sitting to standing and standing to sitting but also<br>reclines and lifts the seat and back position. The product<br>provides indoor and outdoor mobility. |
| Description of<br>the Device: | The LEVO combi powered wheelchair is centre wheel<br>driven, battery powered, motor driven and is controlled<br>by the Penny & Giles compact power wheelchair<br>controller Pilot+. The joystick is integrated in the<br>controller.<br>The wheelchair is powered by two 12V55Ah batteries<br>with a theoretical driving range of 35km on the fully<br>charged batteries.<br>The wheelchair consists of the following basic sub-<br>sections: |

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- Base with two direct-drive units with integrated . parking brakes, two 12V55Ah batteries, two 14"x2¾" centre wheels, two 8"x2" front wheels, and one 5½"x1½" rear wheel with suspension.
- Penny & Giles power electronics Pilot+ .
- Seating system including mechanisms for all possible . positions, stand-up actuator and optional lift and/or backrest actuator.

The base is of welded steel construction and includes the base frame, front castor wheels, centre driving wheels with drive unit (motor/gear/brakes), batteries and pivoting rear castor. The motor controller is mounted to the left or right armrest, depending on the user's needs,

### Substantial Equivalence:

The LEVO combi is substantial equivalent with respect to intended use, and materials to the predicate device. The key changes are rear suspension, outdoor mobility. the use of the Pilot+ controller from Penny & Giles instead of the PG8 controller from Penny & Giles, as well as additional possibilities to change positions (reclining up to lying, relax position).

## Safety and Effectiveness:

LEVO combi was basically developed The on experience of the LEVO mobil LCM. However being able to provide additional outdoor mobility as well as further improvements in the geometric for an excellent biomechanical response to the user's body, there are a few additional functions and adjustments integrated. The rest of it is simply colour and design changes. So the LEVO combi has in substantial the same technological characteristics and the same safety and effectiveness as the predicate device(s) and the minor changes declared in the submission do not raise new questions of safety and effectiveness.

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### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 2 2003

LEVO AG c/o Mr. Stefan Preiss TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112

Re: K030893

Trade/Device Name: LEVO combi Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: II Product Code: IPL Dated: March 21, 2003 Received: March 21, 2003

Dear Mr. Preiss:

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's 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 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 - Mr. Stefan Preiss

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 premar:et 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,

sincerely yours,

Mark N. Mulkerson

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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## Statement of Indication for Use

#### Device Name: LEVO combi

## Intended Use:

The LEVO combi stand-up electrical power wheelchair is a product which changes peoples position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.

### Target Population:

For all individuals who need a power wheelchair with the possibility to change positions and who can not stand on their feet themselves such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Mark N. Milken

Division Sign-Of Division of Genera storative and Neurological L . ces K 030893

510(k) Number_

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