COMBI SELF PROPELLED SHOWER COMMODE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized lines that resemble a human figure, with the lines curving and flowing together. The text is arranged in a circular pattern around the symbol. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 0 2004 Phillip L. Harris Area Sales Manager Kjaerulff Rehabilitation A/S Orkebyvej 6 DK-5450 Otterup Denmark Re: K040677 Trade/Device Name: Combi Self Propelled Shower Commode Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: II Product Code: IOR Dated: April 29, 2004 Received: May 6, 2004 Dear Mr. Harris: We have reviewed your Section 510(k) premarket notification of intent to market the device w o have 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). and Cosmotie For (110) Rate 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 Codc 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. {1}------------------------------------------------ ## Page 2 - Phillip L. Harris This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to begin mailing of substantial equivalence of your device to a legally prematics notification " 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 If you desire specific at regional (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Whisoraliums of Yererence to presensibilities under the Act from the Division of Small other general 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 A Milhesson 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 {2}------------------------------------------------ ## Indications for Use K040677 510(k) Number (if known): SELF- PROPERTYED (OMBI Device Name: Indications For Use: Spl. or attendant operated , ropelled Shower Common hospitalised or disabled uce Kjaerulff REHABILITATION A/S REHABILITATION A/S Ørkebyvej 6 • 5450 Otterup tlf. 63 82 20 55 • www.kjaerulff.com Prescription Use (Part 21 CFR 801 Subpart D) AND/OF Over-The-Counter Use (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) Mark A. Milkerson Division Sign-Off Division of General, Restorative, and Neurological Devices 510(k) Number K040671 Page 1 of