THE MULTILIFT

K024346 · Services Industriels Savaria, Inc. · ING · Mar 4, 2003 · Physical Medicine

Device Facts

• Record ID: K024346
• Device Name: THE MULTILIFT
• Applicant: Services Industriels Savaria, Inc.
• Product Code: ING · Physical Medicine
• Decision Date: Mar 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3930
• Device Class: Class 2

Indications for Use

The Multilift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence.

Device Story

Multilift is an electrically driven, wall-mounted or self-standing platform lift; enables wheelchair users to travel between floors in residential settings. Device operates via electrical power to move platform vertically. Used by individuals in wheelchairs; provides accessibility within private homes. Output is mechanical movement of platform; assists patient mobility and independence.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Steel construction; electrically driven vertical platform lift; wall-mounted or self-standing configuration.

Indications for Use

Indicated for individuals in wheelchairs requiring mechanical transport between floors in a private residence.

Regulatory Classification

Identification

A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a guided platform to move a person from one level to another, with or without a wheelchair. A portable wheelchair elevator is a motorized lift device that is not permanently mounted in one location and that is intended for use in mitigating mobility impairment caused by injury or other disease by providing a means to move a person, with or without a wheelchair, from one level to another (e.g., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).

Special Controls

(i) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the platform in the event of a device failure; (ii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the device to withstand the rated load with an appropriate factor of safety; (iii) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate the ability of the enclosures to prevent the user from falling from the device; and (iv) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized editions of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety.

Predicate Devices

• Savaria V-1504 Vertical Platform Lift (K960739)

Submission Summary (Full Text)

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K024346

## 510(k) SUMMARY

MAR 0 4 2003

| Submitted by: | Barnes, Richardson & Colburn<br>1225 Eye Street, N.W.<br>Washington, D.C. 20005 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Stephen W. Brophy<br>Tel: [phone] |
| Date Prepared: | December 16, 2002 |
| Subject Device: | Savaria Mult-lift |
| Predicate Device: | Savaria V-1504 Vertical Platform Lift<br>(K960739). |
| Subject Product<br>Description: | The Multilift is similar to other products in commercial distribution.<br>These products, like the Multilift, utilize electrically driven, wall-mounted<br>on self-standing platform units to enable individuals in wheelchairs to<br>travel up and down between floors in a residential or public setting. See<br>attached product information on Savaria's V-1504 Vertical Platform Lift<br>(K960739). |
| Intended Use: | The Multilift is intended to mechanically transport an individual in a<br>wheelchair directly between floors in a private residence. |
| Product<br>Comparison: | The Multilift is substantially equivalent in design and function to Savaria's<br>V-1504 Vertical Platform Lift (K960739). Also of steel construction, the<br>V-1504 lift uses principally the same design as the Multi-lift. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 4 2003

Services Industriels Savaria, Inc. c/o Mr. Stephen W. Brophy Barnes, Richardson & Colburn 1225 Eye Street, N.W., Suite 1150 Washington, DC 20005

Re: K024346

Trade/Device Name: Multilift: Vertical Platform Lift Regulation Number: 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: February 5, 2003 Received: February 5, 2003

Dear Mr. Brophy:

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. Stephen W. Brophy

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/dsma/dsmamain.html

Sincerely yours,

L. Mark M. Millerms

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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510(k) NUMBER (IF KNOWN) : i (O24346

DEVICE NAME : Multilift: Vertical Platform Lift

INDICATIONS FOR USE:

The Multilift Vertical Platform Lift is intended to mechanically transport an individual in a wheelchair directly between floors in a private residence.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109 OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1)

Mark A. Miller

1. Restorative revices 18000 222 322 2012

K024346