SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)

{0}------------------------------------------------ OTTO Bock HEALTH CARE 1622924 # OCT 1 7 2002 A COMPANY OF THE OTTO BOCK GROUP North American Parkway N., Suite 100 Two Carlson Parlsway N., Suite 100 Minneapolis, M., S.J., Suite 100 Tollate 203-533-94664 Toull-fee 1-800-328-91464 Bourfree 1-800-328-40 Fax 801-956-2401 ## 510(k) SUMMARY of SAFETY and EFFECTIVENESS # A. General Information :一 ・ | <b>A. General Information</b> | | Toll-free 1-800-328-4058<br>Fax 763-519-6153<br>Toll-free Fax 1-800-962-2549<br>www.ottobockus.com | |-------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. Submitter's Name: | Otto Bock Health Care, Inc. | Technical Center<br>14800 28th Avenue North, Suite 110<br>Minneapolis, MN 55447-4873<br>Phone 763-519-9000<br>Toll-free 1-800-795-8846<br>Fax 763-519-6151<br>Toll-free Fax 1-800-810-7994<br>www.ottobockus.com/services | | 2. Address: | Two Carlson Parkway N., Suite 100<br>Minneapolis, MN 55447-4467 | | | 3. Telephone: | 763-553-9464 | | | 4. Contact Person: | E.P. (Bert) Harman | Customer Support &<br>Distribution Center<br>14630 28th Avenue North<br>Minneapolis, MN 55447-4821<br>Phone 763-553-9464<br>Toll-free 1-800-328-4058<br>Fax 763-519-6150<br>Toll-free Fax 1-800-962-2549 | | 5. Date Prepared: | August 14, 2002 | | | 6. Registration Number: | 2182293 | | | <b>:. Device</b> | | Design & Manufacturing Center<br>3820 Great Lakes Drive<br>Salt Lake City, UT 84120-7205<br>Phone 801-956-2400 | | 1. Name: | Sherpa Mobility System<br>(Manual Wheelchair) | | | 2. Trade Name: | Sherpa Mobility System<br>(Manual Wheelchair) | | | 3. Common Name: | Manual Wheelchair | | | 4. Classification Name: | Manual Wheelchair | | | 5. Product Code: | IOR | | | 6. Class: | I | | | 7. Regulation Number: | 890.3850 | | {1}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles merging into a single form, resembling a bird in flight. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # OCT 1 7 2002 Otto Bock Healthcare E. P. (Bert) Harman CEO/President 2 Carlson Parkway, North Suite 100 Minneapolis, Minnesota 55447-4467 Re: K022924 Trade/Device Name: Sherpa Mobility System (Manual Wheelchair) Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: August 14, 2002 Received: September 4, 2002 Dear Mr. Harman: 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. Iisting 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. {2}------------------------------------------------ Page 2 - Mr. E. P. (Bert) Harman 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Milburn for Celia M. Witten, Ph.D., M.D. 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 {3}------------------------------------------------ ### 510(k) Number: To be determined Sherpa Mobility System (Manual Wheelchair) Device Name: Indications for Use: - Manual transportation device for person who are unable to walk or have a . walking impediment, propulsion by an attendant. : : : ### PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR OVER-THE-COUNTER USE (optional Form 1-2-96) Mark N. Millison (Division Sign-Of Restorative and rous ological De 510(k) Number .