HANDIVIPP

{0}------------------------------------------------ HandiNor 510(k) Premarket Notification K033125 HandiVipp # OCT 3 0 2003 #### 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. Date Prepared: September 29, 2003 510(k) Number __ Submitter's Name, Address and Contact Person HandiNor as Heiasvingen 65 N-1900 Fetsund Norway Contact Person: B. Chiponis President, Lake Shore Consulting, LLC Trade Name: HandiVipp Common Name: Manual Wheelchair Classification Name: Wheelchair, mechanical #### Predicate Devices The HandiNor HandiVipp wheelchair is substantially equivalent to the Sunrise Medical Quickie TSR (K952641). #### Intended Use The HandiNor HandiVipp is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Handivipp is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. {1}------------------------------------------------ ### Technological Characteristics and Substantial Equivalence ### Device Description The HandiVipp comfort wheelchair, "HandiVipp", is a manually operated, self propelled or attendant propelled mechanical wheelchair. The HandiVipp 's intended use is to provide mobility to persons who may require specialized postural support and tilting features to assist in feeding and pressure relief. It is designed to meet the mobility and positioning needs of individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis. Cerebral Palsy. Muscular Dystrophy, Multiple Sclerosis and the like. The HandiVipp frame is constructed from both 22 mm and 18 mm outside diameter (OD) round, mechanical, steel tubing. The side frames are of welded construction and are secured to the remaining frame members using screws and bolts. This device is a rigid wheelchair that incorporates a solid seating surface. The back frame can be folded by releasing a bolt. The seating plate (plain seat) has different hooks and different height levels on the hooks (short (standard), long and plain). This type of seat makes the chair easily adaptable to the various types of wheelchair cushions and seating systems. ## Substantial Equivalence Comparison The HandiNor HandiVipp wheelchair is substantially equivalent to the Sunrise Medical Quickie TSR (K952641). ## Performance Data The HandiNor HandiVipp wheelchair passed all technical requirements identified in ISO 7176: parts 1, 3, 5, 7, and 8. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three abstract shapes that resemble a bird. Public Health Service OCT 3 0 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 HandiNor USA, Inc. C/o Ms. Barbara Chiponis Lake Shore Consulting, LCC 17610 26th Avenue North Plymouth, Minnesota 55447 Re: K033125 Trade/Device Name: HandiNor HandiVipp Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: September 29, 2003 Received: September 30, 2003 Dear Ms. Chiponis: 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 (OS) 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. Barbara Chiponis 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Mark N. Millikan 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 {4}------------------------------------------------ 510(k) Number (if known):_ Device Name: Indications for Use: The HandiNor HandiVipp is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Handivipp is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. The HandiNor HandiVipp is indicated for individuals with postural challenges e.g. Individuals with Scoliosis, Kyphosis, Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, CVA, Spinal Chord injury, Spina Bifida, ALS and similar Neuromuscular and Musculoskeletal pathologies. b Mark N. Milken. (Division Sign-Off) Division of General, Restorative and Neurological Devi. 510(k) Number_ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)