LSC, MODEL 3

{0}------------------------------------------------ K061726 Page 1 of 3 EXHIBIT #1 Image /page/0/Picture/1 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there is an abstract graphic that appears to be composed of vertical lines of varying heights. The lines are arranged in a way that suggests a stylized representation of a cityscape or a series of standing figures. The overall design is simple and modern. LifeStand "Vivre-Debout" Rond-point de Rosarge 40, rue Palverne - 01700 LES ECHETS-FRANCE Tel : +33(0)4 37 26 27 28 Fax :+33(0)4 37 26 27 29 VAT :FR 23 312 906 613 00079 BEC - 4 2006 # 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________ - 1. Submitter's Identification: Lifestand Rond-point de Rosarge 40, rue Palverne F 01700 LES ECHETS-FRANCE Date Summary Prepared: June 12, 2006 - 2. Name of the Device: LSC - 3. Common or Usual Name: powered standup wheelchair ### 4. Device Description: The LSC is a powered standup wheelchair. It is propelled and steered by varying the speed of the two back wheels. Front castors support the front of the caain and allow indirect steering through the turning back wheels. An electric lineanan anot system puts the seat into a seating or standing position. | Maximum end-user weight | : | 120 kg | |-------------------------|---|---------------------------------------------| | Wheelchair width | : | 67 cm | | Wheelchair length | : | 87-109 cm | | Frame | : | Rigid, in magnesium, epoxy paint | | Seat | : | Depth adjustable, with sore proof cushion | | Backrest | : | Inclinable. Folds down for transport | | Upholstery | : | Polyester fireproof material (M4), washable | | Foot-rests | : | Height adjustable | | Front wheels | : | Ø 200mm x 50mm, solid | | Rear wheels | : | Ø 350mm x 70mm, solid | | Brakes | : | automatic electro-magnetic brake and | | | | manual standard parking brake | | Propulsion | : | electric powered | | Elevation | : | electric powered | | Rear stabilization | : | Anti-tip wheels (optional). | | Idle weight | : | 94.7kg | ### 5. Intended Use: {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a logo with the text "LIFESTA" at the bottom. Above the text, there are three vertical lines of varying heights. The lines appear to be connected at the top, forming a stylized graphic element. The image is in black and white. The LSC offers electrically operated seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifibia, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. ### 6. Comparison to Predicate Devices: The LSC is substantially equivalent to its forerunner model LSC Compact by Lifestand, K041535 and the standup wheelchair LCM by LEVO, K963817 - Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows: To approve the performance of the LSC, tests according to current applicable standards where performed at test-laboratories of European notified bodies: | EN 12182: 1999 | Technical aids for disabled persons. General requirements<br>and test methods | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | EN 12184: 1999 | Electrically powered wheelchairs, scooters and their chargers<br>-requirements and test methods | | ISO 7176-1: 1999 | Wheelchairs. Determination of static stability | | ISO 7176-2: 2001 | Wheelchairs. Determination of dynamic stability of electric<br>wheelchairs | | ISO 7176-3: 1988 | Wheelchairs. Determination of effectiveness of brakes | | ISO 7176-4: 1997 | Wheelchairs. Energy consumption of electric wheelchairs and<br>scooters for determination of theoretical distance | | ISO 7176-5: 1986 | Wheelchair tests. Methods for determination of overall<br>dimensions, mass and turning space | | ISO 7176-6: 2001 | Wheelchairs. Determination of maximum speed, acceleration<br>and deceleration of electric wheelchairs | | ISO 7176-7: 1998 | Wheelchairs. Measurement of seating and wheel dimension | | ISO 7176-8: 1998 | Wheelchairs. Requirements and test methods for static,<br>impact and fatigue strength | | ISO 7176-9: 2001 | Wheelchairs. Climatic test for electric wheelchairs | | ISO 7176-10: 1988 | Wheelchairs. Determination of obstacle-climbing ability of<br>electric wheelchairs | | ISO 7176-14: 1997 | Power and Control systems for electric wheelchairs –<br>Requirements and test methods | | ISO 7176-15: 1996 | Wheelchairs. Requirements for information disclosure,<br>documentation and labeling | | ISO 7176-16: 1997 | Wheelchairs - Part 16: Resistance to ignition of upholstered<br>parts - Requirements and test methods | | ISO 7176-20: 2001 | Wheelchairs. Determination of the performance of stand-up<br>type wheelchairs | | ISO 7176-21: 2003 | Wheelchairs. Requirements and test methods for<br>electromagnetic compatibility of electrically powered<br>wheelchairs and motorized scooters | | EN ISO 10993-1: 2003 | Biological evaluation of medical devices. Evaluation and<br>testing | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with the word "LIFESTAND" at the bottom. Above the text, there is an abstract graphic that appears to be three vertical lines of varying heights. The lines are not solid but seem to be made up of smaller elements, giving them a textured appearance. K061726 Page 3 of 3 Biological evaluation of medical devices. Tests for in vitro EN ISO 10993-5: 1999 cytotoxicity - Discussion of Clinical Tests Performed: 8. Clinical tests were not performed - 9. Conclusions: Lifestand believes that the LSC is substantially equivalent to the predicate and is safe and effective for its intended use. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 4 2006 LifeStand "Vivre-Debout" % Ms. Stefanie D. Bankston Rond-point de Rosarge 40, rue Palverne F 01700 Les Echets- France Re: K061726 Trade/Device Name: LSC Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: November 20, 2006 Received: November 28, 2006 Dear Ms. Bankston: 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. {4}------------------------------------------------ Page 2 – Ms. Stefanie D. Bankston 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 (240) 276-0120 . 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours Cahmz Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Exhibit #3 Page ﻠﺴﻴ of 1 K061726 510(k) Number (if known): Device Name: LSC Indications For Use: The LSC offers electrically powered seated and standing mobility to users with ambulatory impairments, including people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc. Prescription Use _ × (Per 21 CFR 801 Subpart D) OR Over-The Counter Use (21 CFT 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) K061726 (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number. K061726