Wu's Powered Wheelchair

{0}------------------------------------------------ Build Correspondence Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. February 16, 2019 Wu's Tech Co., Ltd. Dr. Jen, Ke-Min Contact Person No. 225, Yuan Peir St. Hsin-Chu City. 30093 Cn Re: K181163 Trade/Device Name: Wu's Powered Wheelchair, Mambo 30 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: November 12, 2018 Received: November 20, 2018 Dear Dr. Jen, Ke-Min: 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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Vivek J. Pinto -S for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K181163 ### Device Name Wu's Powered Wheelchair, Mambo 30 Indications for Use (Describe) The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo with the text "Wi's Tech" in red and green. The "Wi's" part of the logo is larger and bolder than the "Tech" part. The logo is surrounded by a green border with rounded corners. The text is in a sans-serif font. 伍氏科技股份有限公司 WU'S TECH CO., LTD elephone/886-3-5382105 No.225 Yuan Peir St. Hsinchu,Taiwan R.O.C E-MAIL:wustech@wustech.com.tw # 5. 510(k) Summary of Safety and Effectiveness (per 21 CFR 807.92) | 510(k) number | K181163 | |------------------------|-----------------------------------------------------------------------------------------------| | Submitter's Name: | Wu's Tech Co., Ltd.<br>No.225, Yuan Peir St., Hsinchu, Taiwan ROC 30093 | | Date summary prepared: | February16, 2019 | | Proprietary Name: | Wu's Powered Wheelchair, Mambo 30 | | Common or Usual Name: | Powered Wheelchair | | Classification Name | Powered Wheelchair<br>Class II, 21 CFR 890.3860 | | Product Code: | ITI | | Contact Person: | Dr. JEN, KE-MIN<br>Email: ceirs.jen@msa.hinet.net<br>TEL: +886-3-5208829, FAX: +886-3-5209783 | | 00Predicate Device | Wu's Tech Co., Ltd.<br>Wu's Powered Wheelchair, Mambo 36<br>K070655 | #### ● Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. ### Device Description: ● ## a) General description The Wu's Powered Wheelchair, Mambo 30, is an indoor-use electric wheelchair that is battery operated. It has a base with six-wheeled with a seat and armrest. The movement of the wheelchair is controlled by the rider who uses joystick, located at the right-side armrest, to control the direction and speed of the wheelchair. The device is provided with an off-board battery charger. The maximum weight capacity of Mambo 30 is 300 lbs. (136 kg), and its maximum speed is 4 mph (6.4 km/h). The following surfaces are recommended NOT to operate on: - Sand surface ◆ - ◆ Wet or icy surface - Road maintenance hole metal cover ◆ - Avoid going up multiple steps. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with the text "WU'S Tech" in red letters. The letters are stylized and have green dots above the "U" and the "S". The logo is surrounded by a green border with rounded corners. The word "Tech" is written in smaller letters below the "WU'S". 氏科技股份有限公司 J'S TECH CO., LTD 統一编號/70711910 新竹市元培街225號 FAX /886-3-5382191 Telephone/886-3-5382105 No.225 Yuan Peir St. Hsinchu,Taiwan R.O.C E-MAIL:wustech@wustech.com.tw - Avoid using escalators. Use the elevator. - � Too steep incline over 6 degrees. - � Ground clearance to battery: 2.34"(60 mm) - Curb climbing ability: 2.34"(60 mm) - b) Principle of operation The Wu's Powered Wheelchair, Mambo 30, is battery-operated, and the battery gives the electric energy to drive the motor. The motor will then drive the wheels to rotate and the wheelchair will thus move forward or backward. If the motor does not receive the electric energy via joystick action, the motor will stop to rotate and this gives the parking brake to the wheelchair. - c) The user population - · The product is intended for the persons restricted to a sitting positon. - · The product is not intended for visually impaired people. - ·The drivers need to be mentally and physically suitable to drive the powered wheelchair. - •The fingers need to work functionally. - · The device cannot be used by children until age of 12 without parental or professional approval. ### ● Performance Testing: - > ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability - イ ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs - く ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes - く ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range - イ ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space - イ ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs - く ISO 7176-7:1998 Wheelchairs - Part 7: Determination of seating dimensions -Definitions and measuring method - く ISO 7176-8:2014 Wheelchairs - Part 8: Static, impact and fatigue strength for manual wheelchairs {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the text "WiU'S Tech" in red letters with a green outline. The letters are stylized and connected, with green dots above the "i" and the apostrophe in "WiU'S". The word "Tech" is written in smaller, black letters below the "S". 氏科技股份有限公司 U'S TECH CO., LTD enhone/886-3-5382105 25 Yuan Peir St. Hsinchu, Taiwan R.O.C. MAIL:wustech@wustech.com.tw - ISO 7176-9:2009 Wheelchairs Part 9: Climatic tests for electric wheelchairs > - V ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs - イ ISO 7176-11:2014 Wheelchairs -- Part 11 Test dummies - く ISO 7176-13: 1989 Wheelchair - Part 13: Determination of coefficient of friction of test surfaces - イ ISO 7176-15: 1996 Wheelchairs -- Part 15: Requirements for information disclosure, documentation and labelling - イ ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices - イ ISO 7176-21:2009 Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers - イ ISO 7176-25:2013 Wheelchairs -- Part 25: Batteries and chargers for powered wheelchairs - イ ANSI/RESNA WC-2:2009 Section 14: Power and control systems for electrically powered wheelchairs-- Requirements and test methods. - く ANSI/RESNA WC-2:2009 Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters. #### ● Biocompatibility evaluation of patient-contacting parts Biocompatibility assessment of patient-contacting components was performed in conformance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. | Patient-contacting Parts | Material's name | Contact classification & contact duration | Tests conducted | |--------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------| | 1. Headrest<br>Seatback Seat<br>Safety seat belt | PVC Vinyl | Surface contacting-<br>Less than 24<br>hours duration | Cytotoxicity +<br>Maximization Sensitization<br>+<br>Skin Irritation tests | | 2. Armrest | PU Foam | Surface contacting-<br>Less than 24<br>hours duration | Cytotoxicity +<br>Maximization Sensitization<br>+<br>Skin Irritation tests | | 3. Horn button | Dow<br>Corning<br>RBB-6671<br>-70 +<br>RBB-6671<br>-70 + | Surface contacting-<br>Less than 24<br>hours duration | Cytotoxicity + Irritation &<br>delayed-type<br>hypersensitivity (Epicutan<br>test) Tests | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with the text "WU'S Tech" in red letters. The letters are stylized with green dots above the "U" and "S". The logo is enclosed in a green rounded rectangle. The word "Tech" is written in smaller letters below the "S". Image /page/6/Picture/1 description: The image shows the name of a company in both Chinese and English. The Chinese characters read "Wu Shi Ke Ji Gu Fen You Xian Gong Si." Below that, the English translation reads "WU'S TECH CO., LTD." The text is in a simple, sans-serif font and is horizontally aligned. 統一編號/70711910 新竹市元培街225號 Telephone/886-3-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu,Taiwan R.O.C. E-MAIL:wustech@wustech.com.tw | | XE20-523-<br>5U +<br>Colourant<br>Techi<br>Black 1801 | | | |-------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | 4. Speed dial | Makrolon<br>6557<br>(PC<br>material ) | <b>Surface</b><br><b>contacting-</b><br>Less than 24<br>hours duration | Cytotoxicity test | | 5. REM060/110<br>bottom case | Makroblen<br>d EL700<br>(PC+PET<br>materials) | <b>Surface</b><br><b>contacting-</b><br>Less than 24<br>hours duration | Cytotoxicity + Irritation &<br>delayed-type<br>hypersensitivity (Epicutan<br>test) Tests | | 6. REM050/100<br>(Full joystick<br>control<br>module) | Makroblen<br>d EL 700 +<br>Makrolon<br>6557 | <b>Surface</b><br><b>contacting-</b><br>Less than 24<br>hours duration | Irritation and delayed-type<br>hypersensitivity Tests<br>(Epicutan test) | ### ● Comparison table | Model<br>Specification | Predicate Device | Subject Device | |----------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Manufacturer | Wu's Tech Co., Ltd. | Same | | Proprietary name, model | Wu's Powered Wheelchair,<br>MAMBO 36 | Wu's Powered Wheelchair,<br>MAMBO 30 | | 510(k) number | K070655 | TBA | | Device classification name | Powered Wheelchair | Same | | Classification regulations | Class II, 21 CFR 890.3860 | Same | | Product code | ITI | Same | | Similarities | | | | Indications for use | The device is intended for<br>medical purposes to provide<br>mobility to persons restricted to<br>a sitting position. | Same indications for use | | Number of wheels | 6 | Same number of wheels | | Front wheel size | 5.05x1.95 inches /solid tires | Same front wheel size /solid tires | | Drive wheel size | 10x3.12 inches /solid tires | Same drive wheel size / solid tires | | Rear wheel size | 5.05x1.95 inches/solid tires | Same rear wheel size / solid tires | | Movement control method | By Joystick control | Same Joystick control | | Motors output &type | 320W x 24V x 2 pcs | Same motors output & type | | Driving system | Middle wheel direct drive | Same middle wheel direct drive | | Brake system | Electromagnetic brake | Same Electromagnetic brake | | Max speed forward | 4 mph / 6.4 km/h | Same forward speed | | Max loading weight | 300 lbs. /136 kg | Same maximum loading weight | | Differences | | | | Dimension (LxW x D inch) | 43.9 x 24.4 x 43.3 inches | 40.6 x 23.8 x 49 inches | | (LxW x D mm) | 1115 x 620 x 1100 mm | 1030 x 605 x 1245 mm | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image is a logo for a company called "Wi's Tech". The logo is in a rounded rectangle with a green border. The text "Wi's" is in red, and the text "Tech" is in a smaller font below the "Wi's". 五氏科技股份有限公司 WU'S TECH CO., LTD 統一編號/70711910 新竹市元培街225號 Telephone/886-3-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu,Taiwan R.O.C. E-MAIL:wustech@wustech.com.tw | Weight with batteries | 226 lbs. /103 kg | 172.7 lbs. / 78.5 kg | |------------------------|------------------------------------------|-------------------------------------------------------------------------------| | Cruising range | 12.5-18.7 miles /20~30 km | 12.8 miles / 20.5 km | | Battery type | 30Ah x 12V x 2 pcs | Kung Long U1-36NE,<br>36Ah x 12V x 2 pcs<br>Complying with ISO 7176-25:2013 | | Charger Type | Off-board charger | Off-board charger | | Brand & Model | HP8204B | CTE 4C24050A | | Rating | Input: AC115/230V,<br>Output: DC 24V, 3A | Input AC 100-240V,<br>Output DC 24V, 5 Amp<br>Complying with ISO 7176-25:2013 | | Electronic controller | PG VR-2 60A | DYNAMIC LINX 40A<br>Complying with ANSI/RESNA WC-<br>2:2009 Section 14 | | Slope grade ability | 8° | 6° | | Operating environments | Indoor/outdoor uses | Indoor use | ### ● Substantial equivalence discussion Both devices have the same indications for use, same technological designs, same number of wheels, same joystick control method, same motor output, same driving system, same brake system, same forward maximum speed, and same maximum loading. In the below, we discuss the differences between them, - V Dimensions: The dimensions of the two devices are similar in Length and Width, but the Depth of the subject device is 5.7 inches (145 mm) larger than the predicate device. The larger depth will give more support to the legs and will bring more comfort to user's ride, and this difference does not raise any new safety and effectiveness concerns for the subject device, since the subject device has passed the ISO 7176 series standards with respect to safety and performance aspects. - V Weight of wheelchair: The weight of subject device is 54 lbs. (25 kg) smaller than the predicate device. This difference will make a lower ratio of the wheelchair weight/motor power output for the subject device. The ratio of the weight/power for the subject device is 172 lbs / 320 W = 0.5375 lbs/W and the predicate device is 0.7063 lbs/W (=226/320). The subject device will use one joule energy per second to push 0.5375 pounds of wheelchair weight, and the predicate device will use one joule energy per second to push 0.7063 pounds of wheelchair weight. That is to say, the subject device consumes less battery's electrical energy than the predicate device. There are no new safety and effectiveness concerns raised for the subject device with respect to the smaller weights. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a logo with the text "WiU'S Tech" in red letters with a green border. The letters "WiU'S" are large and stylized, with two green dots above the "i" and "U". The word "Tech" is smaller and located below the "S". The logo has a rounded rectangular shape with a green border. 統一編號/70711910 新竹市元培街225號 Telephone/886-3-5382105 FAX /886-3-5382191 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:wustech@wustech.com.tw - V Cruising range: In general, the cruising range depends on the wheelchair weight, battery charging condition, motors output, and cruising surface conditions. The cruising range of the subject device is 12.8 miles and that of the predicate device is about 12.5-18.7 miles. The difference between subject device and predicate device is not large. As the user knew the cruising range of the subject device is 12.8 miles from the user manual, they will drive the wheelchair in consideration of 12.8 miles range, and avoid driving exceeding this cruising range for each travel. There are no new safety and effectiveness concerns raised due to this smaller cruising range. - V Battery type: The battery capacity of the subject device is 36 Ah and the predicate device is 30 Ah. A larger battery capacity means this battery can drive a larger range or last for a longer time than a smaller battery capacity under the same usage. Also, the batteries of the subject device have passed the testing of ISO 7176-25:2013. These facts demonstrate there are no any new safety and effectiveness concerns raised due to using a larger battery capacity. - > Charger type: They are the same type of off-board chargers and possess the same input and output voltages, but they are not the same brand and not from the same supplier. But the charger of the subject device has passed the ISO 7176-25:2013, it means the safety and effectiveness aspects of our charger are ensured with respect to the different brand of battery charger. - V Electronic controller: The suppliers and types of the electronic controller are different. But the electronic controller of the subject device has passed the ANSI/RESNA WC-2:2009 Section 14: Power and control systems for electrically powered wheelchairs-- Requirements and test methods, any new safety and effectiveness concerns are not raised due to using a different brand of a controller. - > Slope grade ability: The slope grade ability is 8 degrees for predicate device and 6 degrees for subject device. The relevant statement of 6 degrees for the slope grade ability is placed in the user manual. If the user operates the powered wheelchair according to the instructions for use, any safety and effectiveness concerns are not raised due to a smaller slope grade ability. - > Operating environments: The operating environment for the predicate device is indoor/outdoor uses and it is indoor use for the subject device. The relevant safety statements for riding indoors are placed in the device label and the user manual. The user is instructed to observe the safety statements and follow the instructions {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo with the text "WU'S Tech" in red letters. The letters are stylized and have a rounded appearance. The logo is enclosed in a green border that has rounded corners. The word "Tech" is written in smaller letters below the main text. 統一編號/70711910 新竹市元培街225號 FAX /886-3-5382191 Telephone/886-3-5382105 No.225 Yuan Peir St. Hsinchu, Taiwan R.O.C. E-MAIL:wustech@wustech.com.tw for use. There will be no any new safety and effectiveness concerns raised with respect to its intended use of operating environments. ### CONCLUSIONS ● The subject device, Mambo 30, is as safe and effective as, and functions in a manner equivalent to the predicate device, Mambo 36. The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus, the subject device is substantially equivalent to the predicate device.