LIFTKAR PT

{0}------------------------------------------------ # KIII858 NOV - 4 2011 #### 510(k)Summary #### SANO Transportgerate GmbH LIKFTKAR PT™ -S, Powered Patient Transport Device PRODUCT CODE ILK Regulation Name Powered Patient Transport 890.5150 Class II #### Submitter's Information SANO Transportgeraete Gmbh Am Holzpoldigut 22 Lichtenberg/Linz Upper Austria 4040 Austria Telephone 43(0) 7239/510-10-10 Fax 43 (0_7239/510-10-14 Manfred Winkler Managing Director Dated Prepared: 08/21/11 Revised on 10.5.11 #### Name of Device and Sponsor LIFTKAR PT™-S Product of SANO Common Name Integrated Seat Stairclimber ### Classification Name Powered Patient Transport Predicate Device C-Max-U2 (AAT Alber Antriebstechnik GmbH) K103122 #### *Intended Use The product is a method of transporting a disabled person up and down stairs while seated on the stairclimber and not in a wheelchair. This is done with a battery powered lifting mechanism. The LIFTKAR PT-S requires a certified attendant and can be use on any stairs indoor or outside. 1/6 {1}------------------------------------------------ K111858 #### Device Description The LIFTKAR PT™ S is an attendant operated, battery powered lifting device that transports a disabled person in an integrated chair up or down stairs, not in a wheelchair. The LIFTKAR PT-S is designed for indoor and outdoor use allowing mobility for the person needing assistance. *Attendants are trained and certified before using the device. The portable stair-climber LIFTKAR PT-S can be dismantled into three parts, the climber unit with integrated seat, the battery pack and the handle which includes backrest and armrest. All parts are lightweight and easy to stow away. | Product | PT-S | |---------------------------------|--------------------------------------------------------| | Technical Data | | | Weight (total): | 67 lbs | | Safe Workload (incl. chair | 352 lbs persons wt. | | Overall height: | 44.49 inches | | Overall width: (w/o armrests) | 19.88 inches | | Depth (footrest out) | 29.3 inches | | *Stair Landing minimum: stairs) | 31.5 x 35.4 inches (Includes landings for all types of | | Maximum Stair Height | 8.25 inches | | *Any Stair Type Depth: | 6 inches (includes winding) | | *Straight stair width: | 23.81 inches (includes Liftkar plus 3.93 inches) | | *Winding Stair Width: | 23.81 inches from point of stair depth of 6 inches | Battery Sealed lead gel Capacity with fully charged batter 300-500 steps Battery capacity 2x 12V5 ah 2/6 {2}------------------------------------------------ # KI11858 #### Nominal output voltage of charged 24 V Main components: Handle, lifting device, battery *Climbing Speeds 10 steps per minute I 14 steps per minute II III 18 steps per minute Continuous Mode may be used, if stairs are straight, and there is no landing. Contiuous mode is 18 steps per minute. It is recommended for professional use only. ### Liftkar PT-S Image /page/2/Picture/10 description: The image shows a stair climbing wheelchair. The wheelchair has a black seat and backrest, with armrests on either side. It has a handle at the top for pushing, and wheels at the bottom for moving. The wheelchair is designed to help people with mobility issues climb stairs. 3/6 {3}------------------------------------------------ K11/858 #### Substantial Equivalence The LIFTKAR PT™ S is substantially equivalent in intended use, design and function to the C-Max-U2 K103122 manufactured by AAT. C-Max Image /page/3/Picture/4 description: The image shows two different views of what appears to be a stair climbing wheelchair. The top view shows the wheelchair in its upright and functional configuration, with a seat, backrest, armrests, and wheels. The bottom view shows the wheelchair folded or collapsed, presumably for storage or transport, with the seat and backrest folded down and the frame compacted. 4/6 ୍ଦ > ్రామ 35 {4}------------------------------------------------ # KII1858 Listed Below are the similarities or differences: #### Product Comparison | Weight (total): | 78.7 lbs | 67 lbs | |-----------------------------------------------------|------------------------|---------------------| | Safe Workload (incl. chair) | 352 lbs | 352 lbs persons wt. | | Overall height: | 44.4 inches | 44.49 inches | | Overall width: (w/o armrests) | 16.9 inches | 19.88 inches | | Depth (footrest out) | 30.9 inches | 29.3 inches | | Stair Landing minimum: | 31.5 x 35.4 inches | 31.5 x 35.4 inches | | Maximum Stair Height | 8.26 inches | 8.25 inches | | Battery | Sealed lead acid | Sealed lead gel | | Capacity with fully charged battery | 300 steps | 300-500 steps | | *Speeds | 8-23 steps/min | 10-18 steps/min | | | Continually adjustable | Continuous Mode | | Battery capacity | 2x 12V 5 ah | 2x 12V5 ah | | Nominal output voltage of charge | 24V | 24 V | | Main components:<br>Handle, lifting device, battery | Same | Same | C-Max-U2 PT-S #### Performance Data The LIFTKAR PT™-S was tested by BERLIN CERT Pruf und Zertifizierstelle for Medizinnprodukte GmbH an der Technischen Universitat Berlin, TEST Reports in Section: 11.7-32 LIFTKAR PT -S conforms with the following standards : 5/6 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by three instances of the number '1'. After the '1's, there is the number '8', then the number '5', and finally the number '2'. The characters are written in a clear, legible font. ISO 7176-23:2002 Requirements and Test Methods for attendant - operated stair climbing devices Biocompatibility DIN EN ISO 10993-5 Biological Evaluation and testing of Cytotoxicity The performance Data results of the testing confirm that the device meets specifications for performance criteria and the functions it was intended for. And is substantially equivalent to the predicate device. #### Conclusion Based on the design, performance specifications, testing, and intended use, the LIFTKAR PT™ -S is substantially equivalent to the legally marketed device, C-Max k103122 Since the device is essentially the same as the powered patient transporter already marketed, (C-Max K103122), no effect on the safety and or effectiveness of the device is expected. * Denotes corrections made or added relating to 9.28.11 from FDA re: K111858 Liftkar PT-S (Also underlined) 6/6 {6}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol is text arranged in a circular pattern, spelling out "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SANO Transportgeracte GmbH % Mobility Lifter, LLC Ms. Jeanine A. Carroccio 4028 Belleaire Lane Downers Grove, Illinois 60515 NOV - 4 2011 Re: K111858 Trade/Device Name: LIFTKAR PT™-S Regulation Number: 21 CFR 890.5150 Regulation Name: Powered patient transport Regulatory Class: II Product Code: ILK Dated: September 28, 2011 Received: October 12, 2011 Dear Ms. Carroccio: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {7}------------------------------------------------ Page 2 - Ms. Jeanine A. Carroccio CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Eric Keith Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## 510(k) Number: 《11858 Device Name: LIFTKAR PT™-S Indications For Use: The LIFTKAR PT™-S Is a method of transporting disabled persons, up and downstairs while seated on the stairclimber, and not in a wheelchair. This is done with a lifting mechanism. It is a battery on the bailed in the been and on a certified attendant and can be used on any stairs indoors or outside. | Prescription Use | _______________ | |------------------|-----------------| |------------------|-----------------| AND/OR Over-The-Counter Use___X__ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) sion Sign-Off (Divisio (Division Sign of Surgical, Orthopedical Division. and Restorative Devices 510(k) Number K111858