GENESIS VERTICAL PLATFORM LIFT

{0}------------------------------------------------ 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. | {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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 {3}------------------------------------------------ ## 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) ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Concurrence of CDRH, Office of Device Evaluation (ODE) Mullum Revision Sign-Off