LEVO COMFORT II

K051387 · Levo AG · IPL · Jun 10, 2005 · Physical Medicine

Device Facts

• Record ID: K051387
• Device Name: LEVO COMFORT II
• Applicant: Levo AG
• Product Code: IPL · Physical Medicine
• Decision Date: Jun 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing and Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.

Device Story

LEVO comfort II is a center-wheel-driven, battery-powered stand-up power wheelchair. It utilizes a PG Drives Technology 'VSI' controller with an integrated joystick for user operation. The device features a welded steel base, motor/gear/brake drive units, and a seating system with an integrated stand-up mechanism and actuator. It allows users to transition between sitting and standing positions, including intermediate angles, while providing indoor and outdoor mobility. The device is intended for individuals unable to stand independently. It is operated by the user via the joystick controller. The device benefits patients by facilitating standing, which may provide biomechanical and functional advantages.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics similar to the predicate devices.

Technological Characteristics

Welded steel base frame; center-wheel drive; PG Drives Technology 'VSI' controller; battery-powered (12V/26Ah, 12V/40Ah, or 56Ah configurations); integrated stand-up actuator mechanism; 14-inch rear drive wheels and 8-inch front castor wheels.

Indications for Use

Indicated for individuals requiring a power wheelchair 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)
• Quickie Freestyle (K031289)

Submission Summary (Full Text)

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

# KOS1387

## JUN 1 0 2005

#### 510(k) Summary of Safety and Effectiveness

#### LEVO comfort II

| Submitter: | LEVO AG<br>P.O. Box 1272<br>Anglikerstrasse 20<br>CH-5610 Wohlen, Switzerland |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Mr. Markus Burger, Head of R&D<br>Mr. Thomas Raeber, Managing Director |
| E-Mail-Address: | [e-mail]<br>[e-mail] |
| Device Name: | LEVO comfort II |
| Classification Name: | Electrical Power Wheelchair, Stand-up |
| Identification of<br>Predicate Devices: | LEVO mobil LCM (K 963817)<br>Quickie Freestyle (K 031289) |
| Intended Use: | The LEVO comfort II stand-up power wheelchair is a product<br>which changes people's position from sitting to Standing and<br>Standing to sitting but also any position in between. The<br>product provides indoor and outdoor mobility. |
| Description of<br>the Device: | The LEVO comfort II power wheelchair is centre wheel<br>driven, battery powered, motor driven and is controlled by the<br>PG Drives Technology's power wheelchair controller "VSI"<br>The Joystick is integrated in the Controller.<br>The wheelchair is powered by: two 12V/26Ah, two<br>12V/40Ah or four 12V/26Ah batteries with a theoretical<br>driving range of 14km (26Ah), 20km (40Ah) or 28km<br>(56Ah) on the fully charged batteries. |

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## KOSIJ87

The wheelchair consists of the following basic sub-sections:

- Base with two direct-drive units with integrated parking brakes, two 12V/26Ah, two 12V/40Ah or four 12V/26Ah, two 14"x2%" rear wheels and two 8"x2" front wheels.
- PG Drives Technology's power wheelchair controller . "VSI"
- Seating System including stand-up mechanisms and ● actuator.

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

#### Safety and Effectiveness:

The LEVO comfort II was basically developed 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. The only modifications are simply colour and design changes. So the LEVO comfort II 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2005

Levo AG C/o Mr. Stefan Priess TUV America, Inc. 1775 Old Highway 8 New Brighton, Minnesota 55112

Re: K051387

Trade/Device Name: LEVO comfort II Regulation Number: 21 CFR 890.3900 Regulation Name: Standup Wheelchair Regulatory Class: II Product Code: IPL Dated: May 25, 2005 Received: May 27, 2005

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 Priess

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/industry/support/index.html

Sincerely yours,

Miriam C. Provost, Ph.D.

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): not known

Device Name: LEVO comfort II

The LEVO comfort II stand-up power wheelchair may be of interest for Indications for Use: any individuals who needs a power wheelchair and can not stand up on their own such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Intended use: The LEVO comfort II stand-up power wheelchair is a product which changes people's position from sitting to Standing to sitting but also any position in between. The product provides indoor and outdoor mobility.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _XX (21 CFR 801 Subpart C)

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

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(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) **Number**_K051387