HEARTWAY Power Mobility Scooter

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 29, 2015 HEARTWAY Medical Products Co., Ltd. Dr. Ke-Min Jen Official Correspondent No.6 Road 25. Taichung Industrial Park. Taichung City, 40850 TW Re: K150998 Trade/Device Name: HEARTWAY Power Mobility Scooter, Cutie Mini S16 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 13, 2015 Received: August 28, 2015 Dear Dr. Jen, 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 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements {1}------------------------------------------------ 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. If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Michael J. Hoffmann -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) K150998 Device Name Heartway Power Mobility Scooter, Cutie Mini S16 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) _ Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # hael J. Hoffmann This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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 shows the logo for Heartway. The logo features a purple butterfly-like design on top of a blue square. Below the square, the word "HEARTWAY" is written in bold, black letters. A thin, yellow line is also visible on the left side of the logo. HEARTWAY MEDICAL PRODUC ### 5. 510(k) SUMMARY | Submitter's Name: | HEARTWAY Medical Products Co., Ltd. | |-------------------------|-------------------------------------------------------------------| | | No.6, Road 25, Taichung Industrial Park, | | | Taichung, 40850, Taiwan, ROC | | Date summary prepared: | September 24, 2015 | | Device Name: | Proprietary Name: HEARTWAY Power Mobility Scooter, Cutie Mini S16 | | | Common or Usual Name: POWERED SCOOTER | | Classification Name | Motorized Three-Wheeled Vehicle, Class II<br>21 CFR 890.3800 | | Product Code: | INI | | Company contact person: | Mr. Tien-hsing Yang (Email: yhead0722@hotmail.com) | | Official Correspondent: | Dr. KE-MIN JEN (email: ceirs.jen@msa.hinet.net) | | | TEL: 886-3-5208829, FAX: 886-3-5209783 | | Predicate Device | HEARTWAY Lightweight Power Mobility Scooter, S34<br>(K101142). | Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. Description of the device: - Cutie Mini S16 is battery operated and configured with two rear pneumatic ● wheels as the drive wheels and two front pneumatic wheels as the steering wheels. The device uses the upper panel control to control the turning tiller {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. The word "HEARTWAY" is written in bold, black letters below the square. A thin yellow line connects a small yellow circle to the bottom left corner of the blue square, adding a subtle design element to the logo. # FARTWAY MEDICAL PRODUCTS C WEB:www.heartway.com.tw E-mail:sales@heartway.com.tw CERT ISO-9001 CERTIFICATED column mechanism to control the front wheel as the steering directions. Upper panel control is able to control driving forward, driving backward, speed control and lighting function. The main frame is equipped with a rear bumper to allow the device to sustain an impact without damage to the power scooter safety system and with an independent suspension - Tuning tiller column is equipped with the head light, back mirrors, and a swivel seat with the flipping arm-rests, and a lever to move the seat backward and forward. Cutie Mini S16 maximum weight capacity is 300 lbs (135 kg), and the maximum speed is 3.6 mile/hr ( 6 km/hr) Owing to the feature of the body structure, the two rear wheels can always contact the surface, and the device can drive on the rough surface. But the following surfaces are recommended not to operate on: - Sand surface - Wet or icy surface ● - Road maintenance hole metal cover - Too steep incline over 6 degrees. - Turning Radius: 1020 mm / 40.1" - Ground clearance 90 mm / 3.5'' - Curb climbing ability: 60 mm / 2.4" #### Performance Testing: - (1) EMC Test: ANSI / RESNA WC-2:2009 (Section 21) Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods - CISPR 11:2009 - IEC61000-4-2: 2008 - IEC61000-4-3: 2006+A1:2008+A2:2010 ● - IEC61000-4-4:2004 - IEC61000-4-5:2005 - IEC61000-4-6:2008 - IEC61000-4-8:2009 ● - IEC61000-4-11:2004 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with a stylized butterfly design above the word "HEARTWAY". The butterfly is purple and set against a blue square. To the left of the butterfly, there is a thin yellow line with a circle at the top. The word "HEARTWAY" is written in a bold, black font. HEARTWAY MEDICAL PRODUC Image /page/5/Picture/2 description: The image shows two logos on a white background. The first logo is the "TUV CERT" logo, which features the letters "TUV" in a stylized font above the word "CERT" enclosed in a double-lined oval. Below this, there's a rectangular box containing the text "ISO-9001 CERTIFICATED". The overall impression is that of a certification mark, possibly indicating compliance with ISO 9001 standards. - (2) ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999. - (3) ISO 7176-2 Wheelchairs Part 2: Determination of dynamic stability of electric wheelchairs, 2001. - (4) ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012. - (5) ISO 7176-4 Wheelchairs Part 4: Energy consumption of electric wheelchairs for determination of theoretical distance range, 2008. - (6) ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space, 2008. - (7) ISO 7176-6 Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs, 2001. - (8) ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998. - (9) ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs, 1998. - (10) ISO 7176-9 Wheelchairs Part 9: Climatic tests for electric wheelchairs, 2009. - (11) ISO 7176-10 Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs, 2008. - (12) ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012. - (13) ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989. - (14) ISO 7176-14 Power and control system for electric wheelchairs, 2008. - (15) ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996. - (16) ISO 7176-16 Requirements and test methods for resistance to ignition of upholstered parts, 2012. - (17) ISO 7176-21 Requirements and test method electromagnetic compatibility of powered wheelchairs and motorized scooters, 2009. #### Biocompatibility information Patient contacting materials: Seat PVC material. Hand grip PVC material. Seat belt PVC material We tested these patient contacting materials for compliance to the standards ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. We provided Standard Data Report for 510(k) Forms (FDA Form 3654). {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with a purple butterfly-like shape on a blue square. Below the square, the word "HEARTWAX" is written in bold, black letters. A thin, yellow line extends from the left side of the word upwards, ending in a small yellow circle. HEARTWAY MEDICAL PRODUCTS CO.,LTD. NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:886-4-23580357 (Sales) - 23583232 (Rep) FAX:886-4-23590786 Web : www.heartway.com.tw 60 E-mail : sales@heartway.com.tw Image /page/6/Picture/4 description: The image shows two logos. The first logo is the TUV CERT logo, which is a blue logo with the words "TUV CERT" in a stylized font. The second logo is the ISO-9001 CERTIFICATED logo, which is a blue logo with the words "ISO-9001 CERTIFICATED" in a simple font. The logos are placed on a white background. #### COMPARISON TABLE #### Similarities | ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | Safety and<br>effectiveness of<br>subject device<br>compared to the<br>predicate device | |-------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | BRAND NAME | HEARTWAY | | Same brand | | MANUFACTURER | HEARTWAY Medical Products Co., Ltd. | | Same firm | | MODEL NO | S34 | Cutie Mini S16 | Different model | | 510K NO | K101142 | K150998 | New listing with<br>prior submissions | | Proprietary name | Lightweight Power<br>Mobility Scooter Series | Power Mobility<br>Scooter Series | Heavier weight<br>design | | Common or Usual<br>name | Powered Scooter | Powered Scooter | Same name | | Regulation Number | 21 CFR 890.3800<br>Motorized<br>Three-Wheeled Vehicle | 21 CFR 890.3800<br>Motorized<br>Three-Wheeled<br>Vehicle | Same regulation<br>number | | Product Code | INI | INI | Same code | | INTENDED USE | The device is intended<br>for medical purposes to<br>provide mobility to<br>persons restricted to a<br>sitting position. | The device is<br>intended for medical<br>purposes to provide<br>mobility to persons<br>restricted to a sitting<br>position. | Same intended<br>uses | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with a butterfly design. The butterfly is purple and is set against a blue square. Below the square, the word "HEARTWA" is written in black, with only part of the word visible. #### HEARTWAY MEDICAL PRODUCTS CO .. LTD ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN 86-4-23580357 (Sales) · 23583232 (Rep) FAX:886-4-23590786 ww.heartway.com.tw Image /page/7/Picture/3 description: The image shows the email address sales@heartway.com.tw. The email address is written in a sans-serif font. The email address is likely associated with a business or organization. Image /page/7/Picture/4 description: The image contains two logos related to quality certification. The top logo is the "TUV CERT" mark, which is a certification mark indicating that a product or service has been tested and certified by TUV, a reputable testing and certification organization. Below that is a rounded rectangle containing the text "ISO-9001 CERTIFICATED", indicating that the organization or product has been certified to meet the requirements of the ISO 9001 standard for quality management systems. Same material Footplates ABS ABS Same Cross brace Suspension Cross brace Same Back upholstery Fabric Fabric Same Armrest types Flip-backward Flip-backward Same Wheel Lock Push-to-Lock Push-to-Lock Same Seat PVC material Seat PVC material Patient contacting Hand grip PVC material Hand grip PVC material material Safety belt PVC material Safety belt PVC material Same 3 years: Main frame 3 vears: Main frame Warranty 1 years: Controller / gear 1 years: Controller / motor / batteries w/o gear motor / batteries exhaustive and wear parts w/o exhaustive and wear parts {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters at the bottom. Above the text is a stylized purple butterfly shape against a blue square background. To the left of the logo is a thin yellow line with a small yellow circle at the top. ### HEARTWAY MEDICAL PRODUCTS CO.,LTD. NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 TEL:886-4-23580357 (Sales) - 23583232 (Rep) FAX:886-4-23590786 Web : www.heartway.com.tw 6.0 E-mail : sales@heartway.com.tw ## TUV-CERTIFICATED P 0 #### Differences: | ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | Safety and effectiveness of<br>subject device compared<br>to the predicate device | |----------------------------|---------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------| | Frame | | | | | Type | Fixed | Fixed | Same type | | Material | Carbon Steel Pipe | Aluminum Alloy pipe | Lighter material | | Dimensions | | | | | Overall length | 995 mm / 39.0" | 1195 mm / 47.0" | Larger | | Overall width | 490 mm /19.3" | 620 mm / 24.4" | dimensions | | Overall height | 940 mm / 37.0" | 1200 mm / 47.2" | | | Seat dimension | | | | | Seat width | 570 mm /22.5" | 570 mm / 22.5" | Same width | | Seat height | 408 mm / 16" | 635 mm / 25" | Larger height | | | | | | | Weight limit | 100 kgs / 220 lbs | 135 kgs / 300 lbs | Heavier user | | Rear wheels | 8" x 3" solid x 2 | 11" x 4" pneumatic x 2 | Larger size &<br>different type | | Casters | 8" x 3" solid x 2 | 11" x 4" pneumatic x 2 | Larger size &<br>different type | | Turning Radius | 950 mm / 37.4" | 1020 mm / 40.1" | Larger radius | | Ground<br>clearance | 70 mm / 2.8" | 90 mm / 3.5" | Larger clearance | | Kerb climbing<br>ability | 50 mm / 2.0" | 60 mm / 2.4" | Larger ability | | Scooter Weight | w/ batteries 43.6kgs / 96 lbs | w/ batteries 83kgs / 183 lb | Heavier weight | | | w/o batteries 36.6kgs / 81 lbs | w/o batteries 60kgs/132 lbs | | | Maximum speed | 7.8 km/hr (4.875 mile/h ) | 6.0 km/hr (3.6 mile/h ) | Smaller speed | | Incline | 10 degrees | 6 degrees | Safer slope | | Electronics | Penny & Giles<br>S-Drive 45A | Penny & Giles<br>S-Drive 70A | Same type with<br>different volume<br>controllers | | | | | | | Recharger | 24VDC<br>(UL E241359 certified)<br>4C24020A | 24VDC<br>(UL E201162 certified)<br>4C24050A | Different models with<br>UL certificates | | Model | | | | | Motor | 3A, 24V, 270W | 6A, 24V, 400W | Larger power | | Batteries | | | | | | | | | | Quantity | Two | Two | Same quantity | | Type | 12Ah 12VDC | 36Ah 12VDC | Larger capacity | | Range per full<br>charging | 10~15 km / 6~9 miles | 30 km / 19 miles | Longer range | | Biocompatibility | ISO 10993-1:2009<br>ISO 10993-5:2009 | ISO 10993-1:2009<br>ISO 10993-5:2009<br>ISO 10993-10:2010 | More testing | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo with a butterfly design. The butterfly is purple and has four petals. The butterfly is set against a blue square. Below the square is the word "HEARTWA" in black, bold letters. A yellow line extends from the left side of the word to a yellow circle. RTWAY MEDICAL PRODUC NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 4 TEL:886-4-23580357 (Sales) 23583232 (Rep) FAX:886-4-23590786 Web: www.heartway.com.tw E-mail : sales@heartway.com.tw #### COMPARISON DISCUSSION The intended uses for two devices are the same. PG S-Drive electric controller, suspension of cross brace, footplates, armrest type, the warranty of the components are the same. The back upholstery material is also the same and passed the resistance ignition test in accordance with ISO 7176-16. The electronic systems between two devices, for example, the same type of S-Drive with different volume electronic controller, batteries, recharger, and the competent components are from the same suppliers, which were all passed UL certifications. Thus, the same electric safety level for the two devices is assured. There are safer incline capabilities 6° and one more biocompatibility testing ISO 10993-10:2010 for the subject device than the predicate device. This can ensure more safety and biocompatibility for the users. Mainframes of two devices are fixed type, and frame materials of the two devices are different but they both passed the strength and fatigue tests. The safety and effectiveness are ensured. The weight limit of HEARTWAY Lightweight Power Mobility Scooter, S34 is 100 kgs / 220 lbs and the subject device HEARTWAY Power Mobility Scooter Cutie Mini S16 is 135 kgs / 300 lbs. In order to load a heavier user, the subject device must be equipped with larger seat height and larger castors and rear wheels. In order to have a longer cruise range, the {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows a logo for an organization called HEARTWAY. The logo features a purple butterfly-like shape against a blue square. A yellow line connects a small yellow circle to the word HEARTWAY, which is written in bold, black letters. ARTWAY MEDICAL PRODUC Image /page/10/Picture/9 description: The image contains two logos on a white background. The first logo is the "TUV CERT" logo, which is a blue logo with the letters "TUV" on top of the word "CERT". The second logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. The text is in a simple, sans-serif font. motor power and the battery capability must be larger seat height can thus load a larger battery volume. The larger castors and rear wheels lead to larger turning radius, ground clearance, kerb climbing ability. Finally, larger seat height, larger castors and rear wheels, bigger battery add to a heavier weight of the power scooter. The pneumatic tires for the subject device can absorb more impact while driving than the solid tires for the predicate device, thus leading to more comfort. Under normal driving and maintenance conditions, pneumatic tires have the same safety and effectiveness concerns as the solid tires. In a word, the subject device has a higher seat due to the above considerations and thus possessing a higher center of weight, which leads to less stable capabilities and more tip over hazard when moving fast. So, the maximum speed of the subject device is reduced to a safety level. It is 6.0 km/h (3.6 mile/h) for subject device and 7.8 km/h (4.875 mile/h) for predicate device. This limitation can bring more safety level and reduce tip over hazard. Thus, the main difference between two devices is the seat height dimension only. This main difference is equalized by limiting the maximum speed. At last, two devices pass the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC-2, Section 21 for the EMC test. The overall performances of the two devices are substantially equivalent. #### CONCLUSIONS The subject device, HEARTWAY Power Mobility Scooter, Cutie Mini S16, is as safe and effective as, and functions in a manner equivalent to the predicate device, HEARTWAY Lightweight Power Mobility Scooter S34. 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.