GENESIS VERTICAL PLATFORM LIFT

K033469 · Garaventa Accessibility · ING · Jan 7, 2004 · Physical Medicine

Device Facts

• Record ID: K033469
• Device Name: GENESIS VERTICAL PLATFORM LIFT
• Applicant: Garaventa Accessibility
• Product Code: ING · Physical Medicine
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 890.3930
• Device Class: Class 2

Indications for Use

The Genesis Vertical Platform Lift is intended to mechanically transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

Device Story

Genesis Vertical Platform Lift transports mobility-impaired individuals (wheelchair users or ambulatory) between building levels. Device operates in residential or public settings, indoors or outdoors. System utilizes chain hydraulic or acme screw drive; 750 lb capacity; 14-foot max lift height. Controls are low-voltage constant pressure; key switches restrict access to authorized users. Backup systems provided for emergency operation. Healthcare providers or facility managers do not operate the device; it is for patient/attendant use. Output is mechanical vertical movement; benefits include improved accessibility and mobility for users.

Clinical Evidence

No clinical data; bench testing only. Device compliance verified against ASME A17.5 Electrical Code for Elevating Devices and ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts.

Technological Characteristics

Drive systems: chain hydraulic or acme screw. Capacity: 750 lbs. Lift height: up to 14 feet. Controls: low-voltage constant pressure with key switch access. Standards: ASME A17.5, ASME A18.1. Environment: indoor/outdoor. Configuration: integrated shaftway, building shaftway, or unenclosed with guarding.

Indications for Use

Indicated for persons with mobility disabilities, including wheelchair users and ambulatory individuals, requiring transport between levels in residential or public facilities.

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

• V-1504 Vertical Platform Lift (K960739)

Submission Summary (Full Text)

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JAN - 7 2004

K033469 Genesis Vertical Platform Lift

## 3. Summary

..

| Common Device Name: | Elevator, Wheelchair |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Genesis Vertical Platform Lift |
| Predicate Device: | V-1504 Vertical Platform Lift (K960739) as<br>manufactured by Services Industriels Savaria Inc. |
| | See the attached product literature. |
| Device Description: | The Genesis Vertical Platform Lift is designed to<br>transport persons with a mobility disability, either in a<br>wheelchair or ambulatory, up and down between<br>levels of a residential or public facility. |
| | It can be located within with its own integrated<br>shaftway enclosure, located within a building<br>shaftway or be unenclosed other than guarding<br>around the platform area. It is designed for both<br>indoor and outdoor locations. |
| | The Genesis has a capacity of 750 lbs to<br>accommodate a person in a wheelchair and an<br>attendant. The lifting height is up to 14 feet. It is<br>available with a chain hydraulic drive system or an<br>acme screw drive system. Backup systems are<br>available for emergency operation and evacuation. |
| | All controls are low-voltage constant pressure. Use<br>may be restricted to authorized persons with key<br>switches located on the control panels. |
| | The Genesis is built in accordance with ASME A17.5<br>Electrical Code for Elevating Devices and the ASME<br>A18.1 Safety Standard for Platform Lifts and<br>Stairway Chairlifts. |
| | See the attached product literature. |
| Intended Use: | The Genesis Vertical Platform Lift is intended to<br>mechanically transport persons with a mobility<br>disability, either in a wheelchair or ambulatory, up<br>and down between levels of a residential or public<br>facility. |

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

Mr. Norm Cooper Director of Marketing and Customer Relations Garaventa Accessibility 7505 -134A Street Surrey, British Columbia V3W 7B3

Rc: K033469

Trade/Device Name: Genesis Vertical Platform Lift Regulation Number: 21 CFR 890.3930 Regulation Name: Wheelchair elevator Regulatory Class: II Product Code: ING Dated: December 4, 2003 Received: December 5, 2003

Dear Mr. Cooper:

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 for use stated in the enatiment date of 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, de rices that have teen that do not require approval of a premarket approval application (PMA). and Cosmeter for (110) warket the device, subject to the general controls provisions of the Act. The 1 ou may, dierely mains 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 (sec above) into either class II (Special Controls) or class III (PMA), it rryour device to such additional controls. Existing major regulations affecting your device can hay be subject to sach additions, 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 docs not mean r rease oc acvised that 1991 one and that your device complies with other requirements of the Act that 1 27 the altern and regulations administered by other Federal agencies. You must or any I edotal statutes and states requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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. Norm Cooper

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and h your your 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 n you a 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.

Mark N Millburn

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 Indications For Use

510(k) Number: K033469

Genesis Vertical Platform Lift Device Name:

Elevator, Wheelchair

## Indications for Use:

The Genesis Vertical Platform Lift is intended to mechanically transport persons with a mobility disability, either in a wheelchair or ambulatory, up and down between levels of a residential or public facility.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 807 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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