Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Otto Bock. The logo is in black and white and features the company name in a stylized font. Below the name is the phrase "QUALITY FOR LIFE" in a simple, sans-serif font. SEP 1 6 2011 K111278 ### 510(k) SUMMARY of SAFETY and EFFECTIVENESS ## A. General Information | 1. Submitter's Name.: | OTTO BOCK Health Care, LP | |-------------------------|-------------------------------------------------------------------------------| | 2. Address: | Two Carlson Parkway North, Suite 100<br>Minneapolis, Minnesota USA 55447-4467 | | 3. Telephone: | 763-253-5610 | | 4. Contact Person: | William Kabitz, Quality Assurance Manager | | 5. Date Prepared: | May 1st, 2011 | | 6. Registration Number: | 2182293 | #### B. Device , ﻨﺘ | 1. Name: | z10 Push and Brake Assist | |-------------------------|---------------------------| | 2. Trade Name: | z10 Push and Brake Assist | | 3. Common Name: | Powered Wheelchair Mover | | 4. Classification Name: | Wheelchair, Powered | | 5. Product Code: | ITI | | 6. Class: | II | | 7. Regulation Number: | 21 CFR 890.3860 | ## C. Identification of Legally Marketed Predicate Device | 1. Name: | Dane Technologies Wheelchair Mover | |------------------|------------------------------------| | 2. Manufacture: | Dane Technologies | | 3. K Number: | K073701 | | 4. Date Cleared: | January 8, 2008 | #### D. Description of the Device The z10 is a powerful push and brake assist for manual wheelchairs. It can also be converted into the z10-ce add-on drive with tiller control quickly and easily. In this product version, the user drives and controls the wheelchair independently. {1}------------------------------------------------ Otto Bock® JALITY FOR LI #### E. Features The special features of the z10 push and brake assist for wheelchairs includes: - Very good operating performance, including uneven surfaces, thanks . to the motor unit, suspension, and generous ground clearance of 8 cm. - . Optimum traction, even when going uphill or downhill, thanks to the rear-mounted drive. - Range of up to 25 km* for pushing and driving, no creeping loss of . battery capacity thanks to the latest Lithium-lon battery technology. - . Speed control up to 6 km/h in 5 levels at the push of a button. - Hills and slopes up to 20% and obstacle clearance up to 5 cm . possible. - Excellent maneuverability, including indoors. . - . Very quiet operation due to the worm gear motor. #### F. Intended Use Statement In combination with a manual wheelchair, the z10 power add-on drive is intended exclusively as a push and brake assist for the transportation by an assistant of persons who are unable to walk or who have walking disabilities. In combination with a manual wheelchair, the z10-ce power add-on drive is intended exclusively as a power add-on drive with tiller control for individual use by persons who are unable to walk or who have a walking disability, in order to transport themselves. The wheelchair/z10 combination may only be used with the components/options listed in the instructions for use. The z10 power add-on drive may only be used by persons who have received training. Training in use is a prerequisite in order to protect persons from danger and to operate the wheelchair/z10 combination safely and without mistakes. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Otto Bock. The logo is in black and white and features a stylized, cursive font. A registered trademark symbol is present to the right of the text. QUALITY FOR LIFE # G. Technological Characteristics Summary | | z10 | z10-ce | |----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | General | | | | Housing Metal: | Anthracite metallic | | | Drive wheel | 10", airless, grey | | | Steering caster | N/A | 8" dual, airless, grey | | Anti-tipper | | Swinging anti-tipper | | Driving Data | | | | Speed | Max. 6 km/h, 5 levels, continuous fine adjustment within each speed level | | | Range | 25 km according to ISO 7176-4 | | | Max. climbing ability | Up to 20% | | | Maximum obstacle height | 6 cm | 4 cm | | Turning radius | Depending on the radius of the manual wheelchair | | | Weights | | | | Drive unit (without battery) | 21 kg | | | Tiller control with control panel | 1.5 kg | | | Battery pack | 3.8 kg | | | Wheelchair adapter plate | 1.0 kg | | | z10-ce steering caster unit with adapter | N/A | 8.0 kg | | Total weight, z10 without adapter plate | 26.3 kg | 34.3 kg | | Maximum load capacity (including wheelchair) | 160 kg | | | Minimum load capacity | 20 kg | | | Dimensions (W x H x D) | | | | Drive unit including battery | 335 x 580 x 450 mm | | | Tiller control with control panel | 550 x 520 x 180 mm | | | Wheelchair with z10 | Depends on the manual wheelchair, z10 does not change dimensions | | | Electrical Installation | | | | Lithium-ion battery | 24V / 18.4 Ah | | | Charging time (battery drained) | Approx. 4 h | | | Battery lifespan (complete charging cycles) | 700 cycles (subsequently 80% charging capacity) | | | Control unit | enAble 40 | | | Operating voltage | 24 V DC | | | Motor power | 100 W | | | Self-contacting | Yes | | | Light module | (front) Optional: Hella HL 2000 | | | Wheelchair Adaptation | | | | Minimum seat height | 38 cm | | | Minimum seat width | 38 cm | | | Adaptation system | Attachment bolt with locking pin | | | Compatible Otto Bock wheelchairs | Start M1/M2/M3/M4/M5, Motus, Avantgarde T/VR, Centro A3 | | | Compatible third-party wheelchairs | Adaptable to most wheelchair models commonly available on the<br>market, limitations depending on the product design of the<br>wheelchair, please request a list from Otto Bock | | | Charger | | | | Type | Mentzer | | | Mains plug | Euro-plug, 2-pin | | | Power requirements | 110 V | | | Mains frequency | 50/60 Hz | | | Dimensions (W x H x D) | 170 x 140 x 85 mm | | | Weight | | | {3}------------------------------------------------ Otto Bock® QUALITY FOR LI ## H. Safety Testing The safety of the z10 Push and Brake Assist has been confirmed by CE certification, and was tested by Mikes Testing Partners in Strasskarchen Germany and TÜV SÜD Product Services GmbH, Hanover, Germany to the following standards: ISO 7176-14:2008 ISO 7176-21:2009 ANSI/RESNA WC/Vol. 2 : 1998 ISO 10993-1:2003 Cytotoxicity ISO 9999:2007 Assistive products for persons with disability Refer to Appendic C for test reports. Signatures: Quality Assurance Manager_ President & CEO US Healthcare _ lthcare {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized bird-like symbol in the center. The text around the perimeter appears to be the name of a government agency or organization, possibly related to health and human services. The bird-like symbol in the center is composed of three curved lines, creating a sense of movement and flight. Food and Drug Adminstration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 SEP 16 2511 Otto Bock Healthcare, LP % Mr. William Kabitz Quality Assurance Manager Two Carlson Parkway North, Suite 100 Minneapolis, Minnesota 55447-4467 Re: K111278 Trade/Device Name: 210 and z10ce Push and Brake Assist Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: August 30, 2011 Received: September 02, 2011 Dear Mr. Kabitz: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {5}------------------------------------------------ Page 2 – Mr. William Kabitz 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Pari 803). please go to http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Sincerely yours, FOR Pete Vimmerstedt Mark N. Melkerson Dic Linda Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Otto Bock. The logo is in black and white and features the company name in a stylized font. Below the name is the phrase "QUALITY FOR LIFE" in a simple, sans-serif font. ## APPENDIX J #### Indications For Use Form 510(k) Number (if known): To be determined Device Name: z10 and z10ce Push and Brake Assist Indications for Use: Provide mobility to persons physically challenged and limited to sitting positions due to: - Palsies/Paralyses . - Loss of limbs - Defective and/or deformed limbs ● - Joint contractures . - Joint defects ● - . Other diseases Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ × (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) Signature (Division Sign Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K111278