HEARTWAY Electrically Powered Wheelchairs

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. Above the profiles are three curved lines that resemble wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 27, 2015 HEARTWAY Medical Products Co., Ltd. c/o Dr. Jen, Ke-Min Official Correspondent No.6, Road 25, Taichung Industrial Park Taichung City 40850 Taiwan, R.O.C. Re: K142731 Trade/Device Name: HEARTWAY Electrically Powered Wheelchair, Model P19 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: January 20, 2015 Received: January 28, 2015 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. The general controls provisions of the Act include requirements for annual registration. Isting 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); medical device reporting (reporting of medical {1}------------------------------------------------ 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 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/Resourcesfor You/Industry/default.htm. 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 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, # Felipe Aquel -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) K142731 Device Name HEARTWAY Electrically Powered Wheelchair, Model P19 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) |X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The logo appears to be for an organization or company with a focus on heart-related matters. **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 E-mail sales@heartway.com by | Submitter's Name: | HEARTWAY Medical Products Co., Ltd.<br>No.6, Road 25, Taichung Industrial Park, Taichung, 40850,<br>Taiwan, ROC | |-------------------------------|-----------------------------------------------------------------------------------------------------------------| | Date summary prepared: | February 5, 2015 | | Device Name Proprietary Name: | HEARTWAY Electrically Powered Wheelchair, Model P19 | | Common or Usual Name: | POWERED WHEELCHAIR | | Classification Name: | Class II, 21 CFR 890.3860 | | Product Code: | ITI | | Company contact: | Mr. Henry Wu (henry@heartway.com.tw) | Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. ## Description of the device: The HEARTWAY Electrically Powered Wheelchair, Model P19 is battery powered and configured with four solid wheels, a seat, a controller to control the driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, and a set of anti-tippers. Main frame carries a width foldable seat system and a set of rear anti-tipper to prevent a patient from tipping their wheelchairs backward. P19 maximum weight capacity is 250 lbs (113kg). Maximum speed is 3.75 mph (6 km per hour). The device can be folded for transport and is provided with an external battery charger. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with a purple butterfly-like shape against a blue square. A thin yellow line extends from the top left corner of the square to a small yellow circle above the word "HEARTWA" in bold black letters. The logo appears to be for an organization or company with a name starting with "HEARTWA". EARTWAY MEDICAL PRODU E-mail : sales@heartway.com.tw CERT ISO-9001 CERTIFICATED ## Performance Testing: - 1) EMC Report ANSI / RESNA WC/Vol.2: 2009, CISPR 11: 2004+A2:2006, EN61000-4-2: 2008, IEC61000-4-3: 2006, IEC61000-4-8: 2001 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods). - 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters at the bottom. Above the word is a blue square with a purple butterfly-like shape inside. To the left of the square is a yellow line with a circle at the top. ## HEARTWAY MEDICAL PRODUCTS CO.,LTD. TÜV-FRITZ CERTIFICATED P 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 al E-mail : sales@heartway.com.tw ## COMPARISON TABLE | ITEMS | PREDICATE DEVICE | SUBJECT<br>DEVICE | Safety and<br>effectiveness of<br>subject device<br>compared to the<br>predicate device | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Brand name | HEARTWAY | | Same brand | | Manufacturer | HEARTWAY Medical<br>Products Co., Ltd. | | Same<br>manufacturer | | Series | Lightweight System<br>Series | Electrically<br>Powered<br>Wheelchair | Different series | | Model | P15 | P19 | Different model | | 510K number | K071005 | K142731 | Different<br>submissions | | | Similarity | | | | Intended use | The device is intended<br>for medical purposes<br>to provide mobility to<br>persons restricted to a<br>sitting position. | Same | Same | | Frame<br>Type<br>material | Folded<br>Aluminum alloy | Same | Same | | Weight limit | 115 kgs / 250 lbs | Same | Same | | Footplates | ABS | Same | Same | | Back<br>upholstery | Fabric | Same | Same | | Armrest types | Flip-backward | Same | Same | | Wheel Lock | Push-to-Lock | Same | Same | | Suspension | Cross brace | Same | Same | | Patient<br>contacting<br>material | Seat PVC material<br>Hand grip PVC material<br>Seat belt PVC material | Same | Same | | Biocompatibility | ISO 10993-1:2009<br>ISO 10993-5:2009<br>ISO 10993-10:2010(E) | Same | Same | | Warranty | 3 years: Main frame<br>1 years: Controller /<br>gear motor / batteries<br>w/o exhaustive and<br>wear parts | Same | Same warranty | | Differences | | | | | Maximum<br>speed | 9.6km/h( 6 mph) | 6 km/h(3.75mph) | Smaller speed | | Overall<br>dimension | | | | | Overall length | 940 mm / 37" | 850 mm / 33" | Smaller | | Overall width | 610 mm / 24" | 520 mm / 20" | dimensions | | Overall height | 980 mm / 38.5" | 830 mm / 32" | | | Electronics | P & G, VR2<br>controller | Dynamic LiNX<br>LE System<br>controller | Different<br>controllers | | Batteries | | | | | Quantity | Two | Two | Same | | Type | 22Ah 12VDC | 12Ah 12VDC | Smaller capacity | | Range per<br>charge | 20km / 12.5 miles | 15km / 9.32 miles | Smaller range | | Rear wheels | | | | | Quantities | 2 | 2 | | | Sizes/type | 12 1/2" * 2 1/4"<br>(PU solid tire) | 8" * 2"<br>(PU solid tire) | Smaller tires | | | | | | | Casters | 7" * 1.75"<br>(2 PU solid tires) | 7" * 1.6"<br>(2 PU solid tires) | Smaller castors | | Seat size | | | | | Width | 75 cm / 29.5" | 41 cm / 16.1" | Smaller seat | | Depth | 57 cm / 22.4" | 33 cm / 12.9" | Sizes | | Height | 37.5 cm / 14.8" | 35 cm / 13.7" | | | Curb climbing | 60 mm | 40 mm | Smaller curb | | Dynamic incline angle | 10 degrees | 6 degrees | Smaller angle | | Ground clearance | 120 mm | 40 mm | Smaller clearanc | | Turning radius | 480 mm | 735 mm | Larger radius | | Motor | | | | | Quantity | 2 | 2 | Same | | Type | 24V, 200W | 24V, 150W | Smaller power | | Wheelchair Weight | w/ batteries 43kgs /<br>95 lbs<br>w/o batteries 28.5kgs /<br>63 lbs | w/ batteries<br>36.5kgs /<br>80.5lbs<br>w/o batteries<br>28kgs / 61.7 lbs | 14.5 lbs<br>wheelchair<br>weight<br>difference<br>and smaller<br>battery weight | | Charger | 24VDC<br>(UL 1310 ) | 24VDC<br>(UL E201162) | Different<br>UL-certified<br>chargers | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, black letters. Above the word is a blue square with a purple butterfly-like design inside. To the left of the logo is a thin, yellow line with a small 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 al 60 Image /page/6/Picture/3 description: The image shows two logos. The top logo is the "TUV CERT" logo, with the letters "TUV" stacked on top of the word "CERT". The bottom logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. The text is stacked in three lines. 9 E-mail : sales@heartway.com.tw {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. Below the square, the word "HEARTWAY" 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 al 60 Image /page/7/Picture/3 description: The image shows an email address. The email address is sales@heartway.com.tw. The text "E-mail :" is written before the email address. Image /page/7/Picture/7 description: The image shows two logos. The first logo is the "TÜV CERT" logo, with the word "TÜV" in a stylized font above the word "CERT". The second logo is a rounded rectangle containing the text "ISO-9001 CERTIFICATED". P {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. To the left of the square, there is a yellow circle connected to a vertical yellow line. Below the square and line, the word "HEARTWA" is written in bold, black letters. HEARTWAY MEDICAL PRODUCTS O ## COMPARISON DISCUSSION The intended uses for the two devices are the same. Mainframes of two devices are folded, and frame materials all meet the Strength, Yield Load, and Elongation tests. Weight load, footplates, armrest type, suspension, static incline angle, patient-contacting materials (biocompatibility) and the warranty are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test. Thus the same safety level for the two devices is assured. Basically, the overall dimensions, seat dimensions, rear wheels sizes and front castors sizes of the subject device is smaller than those of the predicate device. Thus, the wheelchair weight for the smaller size of the same aluminum alloy material should be smaller. In order to drive the heavier wheelchair with a faster speed, the motor powers and the batteries capacities of the predicate device must be larger than those of the subject device, based on the work-energy theorem. Since the motor power and battery capacity of the subject device are smaller than those of the predicate device, the cruise range is smaller. These differences are not related to the safety and effectiveness aspects. Owing to the smaller height and smaller wheels and castors, the ground clearance and curb climbing of the subject device are smaller than those of the predicate device. As for the larger turning radius for the subject device, it is due to the different software processing speeds among two different electronic controllers. Two different electronic controllers are certified to function safely and effectively. Thus different radius and different electronic controllers do not raise any safety and effectiveness aspects. They are substantially equivalent. Dynamic incline angle 6 degrees for the subject device is smaller than 10 degrees for the predicate device. This is due to the wheelchair weight of the predicate device is 14.5 lbs heavier than that of the subject device and this comes mainly from the battery weight difference. The battery boxes are all located at bottom of the wheelchairs and it lowers the height of center of gravity of the predicate device. These facts all increase the incline angle of the predicate device. But two devices all pass the ISO 7176-2 standard, the dynamic stabilities of two devices are all assured. There are no safety and effectiveness concerns. They are substantially equivalent with respect to this difference. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo and contact information for Heartway Medical Products Co., LTD. The logo features a stylized purple butterfly-like design next to the company name in bold black letters. Below the name is the company's address, phone and fax numbers, website, and email address. Certifications from TUV and ISO-9001 are also displayed. The battery chargers are different but are the same 24 VDC type. Two chargers are UL-certified and there are no safety and effectiveness hazards. The difference does not raise any safety and effectiveness concerns. Despite of the above differences, the two devices all completed the performance tests in accordance with ISO 7176 series standards and the ANSI / RESNA WC 2, Section 21 for the EMC test. They function safely and effectively. There are no safety and effectiveness aspects concerned. Thus, the two devices are substantially equivalent. ## CONCLUSIONS The subject device, HEARTWAY Electrically Powered Wheelchair, Model P19, is as safe and effective as, and functions in a manner equivalent to the K071005 predicate device, HEARTWAY Lightweight System Series, P15. 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.