K450 POWERED WHEELCHAIR

{0}------------------------------------------------ # ORIGINAL, TRADITIONAL 510(K) NOTIFICATION ORIGINAL, POWERED WHEELCHAIR: K450 Image /page/0/Picture/1 description: The image shows the Permobil logo, which is an oval shape with the word "permobil" written in white letters on a black background. Above the logo, there is some handwritten text that is difficult to read. The logo is simple and easy to recognize, and the black and white color scheme gives it a classic look. ### Attachment 11 ## 510(k) Summary JUL 2 9 2008 : | Submitter | Permobil AB<br>Box 120<br>S-861 23 Timrå<br>Sweden | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone | +46 60 595900 | | Facsimile: | +46 60 575250 | | Contact Person: | Jan Åström | | e-mail address: | jan.astrom@permobil.se | | Date Prepared: | July, 2008 | | Device name: | K450 | | Classification Name: | Powered wheelchair | | Predicate Devices: | C350( K071650) manufactured by Permobil AB. | | Intended use: | The intended use of the K450 powered wheelchair is to provide outdoor and<br>indoor mobility to persons limited to a seated position that are capable of<br>operating a powered wheelchair. | | Description of device: | K450 Powered Wheelchair is battery powered, rear wheel motor driven and<br>is controlled by the PG power wheelchair R-net PM120 amp controller.<br>The user interface is a joystick.<br>The K450 is powered by two 12VDC 60Ah, Group M34 batteries,<br>approximate driving range on fully charged batteries is up to 26,9 km<br>(16,7 miles), depending on use and the terrain the chair is driven on.<br>The chair frame is a welded steel construction and includes two rear drive<br>wheels with drive units (motor, gear, brake), batteries and front pivoting<br>casters.<br>Depending on users needs, the joystick motor control is mounted to the left<br>or right armrest.<br>When the user activates the joystick, the controller receives a signal to<br>release the brakes.<br>With the brakes released, the chair is allowed to move in the direction the<br>joystick is actuated.<br>When the user releases the joystick, the chair slows to a stop and the brakes<br>are automatically re-engaged. The solenoid electromechanical brakes allow<br>the user stop by letting go of the joystick. | 1 {1}------------------------------------------------ # ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: K450 Image /page/1/Picture/1 description: The image shows the logo for Permobil. The logo is in an oval shape with a black background and white text. The text "permobil" is written in a sans-serif font, with the "o" in "mobil" being slightly larger than the other letters. #### Performance Data In all instances, the K450 functioned as intended. #### Substantial Equivalence The K450 is substantially equivalent to the C350(K071650). The K450 has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the K450 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the K450 is as safe and cffective as the C350. Thus, the K450 is substantially equivalent. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 2 9 2008 Permobil AB % Ms. Jan Astrom Box 120 Timra Sweden S-861 23 Re: K081964 Trade/Device Name: K450 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class Il Product Code: ITI Dated: July 10, 2008 Received: July 10, 2008 Dear Ms. Astrom: 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. {3}------------------------------------------------ Page 2 - Ms. Jan Astrom 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 procced to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark M. Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### ORIGINAL, TRADITIONAL 510(K) NOTIFICATION PERMOBIL POWERED WHEELCHAIR: K450 ### INDICATION FOR USE 510(k) number Not assigned at the writing of this submission. K450 Device name: #### Indication for Use The intended use of the K450 series of the powered wheelchair is to provide indoor and outdoor mobility to persons limited to a seating position that are capable of operating a powered wheelchair. Prescription use __ or Over the counter use __ (Part 21 CFR 801 Subpart D) (Part 21 CFR 807 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Marta H. Melkerss (Division Sign-C Division of General, Restorative, and Neurological Dev 510(k) Number K081 Page 1 of 1