LEVO COMPACT-EASY LCE

K973951 · Levo USA · IPL · Dec 23, 1997 · Physical Medicine

Device Facts

• Record ID: K973951
• Device Name: LEVO COMPACT-EASY LCE
• 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 wheelchair is a product which changes position from seating to standing and standing to seating.

Device Story

LEVO Compact-Easy LCE is a manual wheelchair with an integrated electrical power-supported stand-up mechanism. Operated by the user, the device facilitates transition between seated and standing positions. It enables users to reach objects, participate in social interactions at standing height, and perform daily therapy. The device is intended for use by individuals with mobility impairments who cannot stand on their own.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual wheelchair with integrated electrical stand-up mechanism. Main frame: color-painted aluminum. Stressed parts: reinforced brass casting. Upholstery: flame-impeded. Power: two 12V/2.9Ah sealed lead-acid gel batteries (24V total). Motor: Linak Power Drive LA 28.405-150-24-001 (24 VDC, 2500N).

Indications for Use

Indicated for individuals who require a wheelchair and are unable to stand independently, 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 23 1997

Mr. Thomas Raeber LEVO AG Dottikon Bleicheweq 5 CH-5605 Dottikon Schweiz, Switerland

K973951 Re: LEVO Compact-Easy LCE Requlatory Class: II Product Code: IPL Dated: October 9, 1997 October 16, 1997 Received:

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 The general controls provisions of the Act 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. ਸ 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 Activery 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.tml" a

Sincerely yours,

years,

Lily White

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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510(k) Number (if known): . .

K973951

Device Name:

:

# LEVO compact-easy LCE

### Indications For Use:

- The LEVO stand-up wheelchair is a product which changes position from seating to standing and . standing to seating.
#### Target population:

- · For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..
#### Design:

- · An electrical power suported stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
#### Material:

- · Main frame: Colour painted aluminium.
- · Major stressed parts: Reinforced brass casting.
- Uphoistery: . Flame impeded.
- · Batterv:
- Stand-up motor: .

2 Gel, sealed lead acid battery (12V/2.9Ah in series=24V/2.9Ah) Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N

#### Performance:

- The LEVO compact easy LCE 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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)

Alan Watts

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)