A-200 POWERED WHEELCHAIR

{0}------------------------------------------------ Otto Bock® ### QUALITY FOR LIFE DEC 2 7 2005 # 510(k) SUMMARY of SAFETY and EFFECTIVENESS ## A. General Information 3. Common Name: 5. Product Code: B. 4. | 1. Submitter's Name: | OTTO BOCK HealthCare LP | |-------------------------|-----------------------------------------------------------------| | 2. Address: | Two Carlson Parkway N., Suite 100<br>Minneapolis, MN 55447-4467 | | 3. Telephone: | 763-489-5105 | | 4. Contact Person: | Bob Clarke | | 5. Date Prepared: | August 15, 2005 | | 6. Registration Number: | 2182293 | | Device | | | 1. Name: | A-200 Powered Wheelchair | | 2. Trade Name: | A-200 Powered Wheelchair | Powered wheelchair Classification Name: Powered wheelchair ן דיין 6. Class: II 7. Regulation Number: 890.3860 {1}------------------------------------------------ Otto Bock® ### QUALITY FOR LIFE ## C. Identification of Legally Marketed Devices | 1. Name: | Evantgarde/Endeavor/A-100 | |------------------|---------------------------| | 2. K Number: | K000739 | | 3. Date Cleared: | October 24, 2000 | ### D. Description of the Device The A-200 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK Health Carc. The A-200 has a closed "U" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor. #### E. Intended Use Statement The A-200 is a rear wheel drive powered wheelchair with caster front wheels for indoor use (primarily) but can be used outdoors as well. These wheclchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user opcrating the Penny and Giles (P&G) VSI Electric Wheelchair Control System that is connected to the Micro Motor. The wheelchair is steered by different rotation of the rear wheels. ## F. Technological Characteristics Summary The A-200 Wheelchair is substantially equivalent to the OTTO BOCK Evantgarde/Endeavor/A-100 Wheelchair, cleared on October 24, 2000 as K000739. Each wheelchair is a powered wheelchair for the active user, with a rigid frame and similar characteristics. The A-200 was tested by TÜV Product Service to the following standards: - . EN 12184 - . ISO 7176 - Series - ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC . with the conclusion that "the test sample fulfills the requirements." {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known): To be determined Device Name: A-200 Powered Wheelchair Indications for Use: Children State State Case Case Cases Canada Caracter Comparentation Comments of Children Comments of Children Comments of Children - Provide mobility to persons physically challenged and limited to sitting positions. . Prescription Use (Part 21 CFR 801 Subpart D) - AND/OR Over-The-Counter Use _ X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Page I of I V V {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 7 2005 Mr. Bob Clarke Otto Bock HealthCare LP Two Carlson Parkway N., Suite 100 Minneapolis, Minnesota 55447-4467 Re: K052706/S1 Trade/Device Name: A-200 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: November 11, 2005 Received: November 15, 2005 Dear Mr. Clarke: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booken v r (c) f the device is substantially equivalent (for the indications for referenced above and have to legally marketed predicate devices marketed in interstate commerce use suited in the enactment date of the Medical Device Amendments, or to devices that prior to way 20, 1970, and cordance 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 therefore, manier the act include requirements for annual registration, listing of devices, good controls provisions of thabeling, 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 may be subject to sam additions, 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 I lease of advisou mar 271 i onethat 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 r carates statutes and registerial of the limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set fabering (21 CFR (21 600) 3 300) 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 - Mr. Clarke This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to obgin hanteeing , " . premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication: "The FDATManig sification 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 acrise of Compliance at (240) 276-0120. Also, please note the regulation entitled, Coliact the Office of Octification" (21CFR Part 807.97). You may obtain other IMISolanding by responsibilities under the Act from the Division of Small Manufacturers, general information on your tespension its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely yours, Barbaco Buehm Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### Indications for Use 510(k) Number (if known): To be determined Device Name: A-200 Powered Wheelchair Indications for Use: - Provide mobility to persons physically challenged and limited to sitting positions. . Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE) Barbara BuemMD & MKM (Division Sign Off) Division of General, Restorative, and Neurological Devices i Page I of I **510(k) Number** k052706/Si .