LEVO MOBIL LCM

K963817 · Levo USA · IPL · Dec 23, 1997 · Physical Medicine

Device Facts

• Record ID: K963817
• Device Name: LEVO MOBIL LCM
• Applicant: Levo USA
• Product Code: IPL · Physical Medicine
• Decision Date: Dec 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LEVO stand-up electrical power wheelchair is a product which changes peoples position from seating to standing and standing to seating.

Device Story

LEVO Mobil LCM is an electrical power wheelchair with an integrated stand-up mechanism. Operated by the user via an electronic controller, the device transitions the user from a seated to a standing position and vice versa. This allows users to reach objects, participate in social interactions at eye level, and perform daily standing therapy independently. The device is intended for use by individuals with mobility impairments who cannot stand on their own. It provides increased independence and functional mobility in various environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Main frame: colour painted steel; stressed parts: reinforced brass casting; upholstery: flame impeded. Power: 2x12V/25Ah or 50Ah sealed lead acid gel batteries. Motors: Bosch 24V DC stand-up motor; Schmid 24V DC driving motors with 12V brakes. Controller: Penny & Giles PG8 electronic controller. Form factor: electrical power wheelchair with integrated stand-up mechanism.

Indications for Use

Indicated for individuals requiring an electrical power wheelchair who are unable to stand, including those with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, and 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Thomas Raeber
*LEVO AG Dottikon
Bleicheweg 5
CH-5605 Dottikon
Schweiz, Switzerland

DEC 23 1997

Re: K963817
LEVO Mobil LCM
Regulatory Class: II
Product Code: IPL
Dated: October 13, 1997
Received: October 20, 1997

Dear Mr. Raeber:

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 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 (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 action. In addition, FDA may publish further announcements 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. Thomas Raeber

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.gov/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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K963817

(k) Number (if known): LEVO mobil LCM

Device Name:

## Instructions For Use:

- The LEVO stand-up electrical power wheelchair is a product which changes peoples position from seating to standing and standing to seating.

## Target population:

- For whole those who needs an electrical power wheelchair and can not stand on their feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

## Design:

- An electrical stand-up mechanism is integrated in an electrical power wheelchair which allows the user to stand up easily when and where ever he wants to.

## Material:

- Main frame: Colour painted steel.
- Major stressed parts: Reinforced brass casting.
- Upholstery: Flame impeded.
- Batteries: 2 x 12 V/25 Ah (serial connected) Gel, sealed lead acid batteries or 2 x 2 x 12 V/25 Ah for higher range (50 Ah).
- Stand-up motor: Bosch-24 V DC, 3.5 A, 84Ah (CE marked).
- Driving motors: Schmid 24 V DC, 8 A, 0.16 KW with 12 V brakes
- Electronic: Penny & Giles PG8 Controller

## Performance:

- The LEVO mobil LCM allows the user to stand up easily when and where ever he wants to. Whether to reach things without help of others, whether take part in discussions standing up and show influence, whether just to do daily therapy individually.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of General Restorative Devices

510(k) Number 5963817

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☑

(Optional Format 1-2-96)