LEVO ACTIVE-EASY LAE

{0}------------------------------------------------ Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Thomas Raeber Managing Director Levo AG Dottikon Bleicheweg 5, CH-5605 Dottikon Schweiz, Switzerland JUL - 3 1997 K971873 Re: LEVO active-easy LAE Requlatory Class: II Product Code: IPL Dated: May 12, 1997 Received: May 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, Druq, 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 Requlations, 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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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. {1}------------------------------------------------ # 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Mark N Milkerner Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ Page _______of_______ . ﺍ # K971873 LEVO active-easy LAE 510(k) Number (if known): __________ Device Name:__________________________________________________________________________________________________________________________________________________________________ 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: - · A manual 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: - Colour painted aluminium. · Main frame: · Major stressed parts: Reinforced brass casting. - Upholstery: Flame impeded. . # Performance: - · The LEVO active-easy LAE 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) | | Mark N Milkers | |---------------|-----------------------------------------| | for | (Division Sign-Off) | | | Division of General Restorative Devices | | 510(k) Number | K971873 | | Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use <div> <span style="text-decoration: underline;">✓</span> </div> (Optional Format 1-2-96) | |---------------------------------------|----|---------------------------------------------------------------------------------------------------------------| |---------------------------------------|----|---------------------------------------------------------------------------------------------------------------|