HEARTWAY Electrically Powered Wheelchair P27

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. 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 June 12, 2015 HEARTWAY Medical Products Co., Ltd. c/o Jen Ke-Min No.6 Road 25, Taichung Industrial Park Taichung City, TW 40850 Re: K142783 Trade/Device Name: HEARTWAY Electrically Powered Wheelchair P27 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: May 12, 2015 Received: May 20, 2015 Dear 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, 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); 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. {1}------------------------------------------------ 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 Carlos L. Peña, PhD, MS for 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) K142783 Device Name HEARTWAY Electrically Powered Wheelchair P27 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. 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 a logo with a stylized butterfly design. The butterfly is purple and is set against a blue square. Below the butterfly is the word "HEARTWA" in black, with only part of the word visible. There is also a yellow circle with a line extending down to the word. EARTWAY MEDICA Image /page/3/Picture/2 description: The image contains two logos on a white background. The top logo is the "TUV CERT" logo, which is a blue circular design with the letters "TUV" in a bold, sans-serif font at the top and the word "CERT" in a smaller font below it. The bottom logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. The text is in a simple, sans-serif font, and the rectangle has a thin, blue border. # 510(k) SUMMARY | Submitter's Name: | HEARTWAY Medical Products Co., Ltd. | |-------------------------|-----------------------------------------------------------| | | No.6, Road 25, Taichung Industrial Park, Taichung, 40850, | | | Taiwan, ROC | | | TEL: 886-4-23580357 / 886-4-23583232 | | | FAX: 886-4-23590786 | | Date summary prepared: | March 20, 2015 | | Device Name | | | Proprietary Name: | HEARTWAY Electrically Powered Wheelchair, Model P27 | | Common or Usual Name: | POWERED WHEELCHAIR | | Classification Name: | Powered Wheelchair, Class II, | | | 21 CFR 890.3860 | | Product Code: | ITI | | Company contact: | Mr. Yang, T. H. (yhead0722@hotmail.com) | | Official Correspondent: | Dr. Jen, Ke-min (ceirs.jen@msa.hinet.net) | | Predicate device | K070489 | Heartway Power Tilt Seating System Power Chair, P16RT #### 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 P27 is battery powered and configured with 2 PU solid front castors and 2 pneumatic rear drive wheels, a width adjustable seat, a controller to control the lighting function and driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, a seat cushion, a pair of skirts, a set of anti-tippers. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo with a butterfly-like design in purple against a blue square. A yellow line extends from the left side of the square, ending in a small circle. Below the square, the word "HEARTWAY" is printed in bold, black letters. The logo appears to be for an organization or company named Heartway. HEARTWAY MEDICAL PRODUCTS C 886-4-23580357 (Sales) - 23583232 (Rep) FAX : 886-4-23 Image /page/4/Picture/2 description: The image contains two logos. The first logo is the "TUV CERT" logo, with the word "TUV" in blue and the word "CERT" in white inside of a blue circle. The second logo is a blue rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. P27 powered wheelchair is rear-wheel driven and operated by two pneumatic rear wheels as the drive wheels, two solid front wheels as the front casters and uses upper joystick to control the driving direction, driving speed, and lighting function. Main frame carries a width adjustable seat system and a set of anti-tipper to prevent a patient from tipping their wheelchairs backward. Main frame is equipped with the front & rear independent suspensions to enhance the stability. A width-adjustable seat system carries a set of back rest system, a seat cushion, a pair of arm-rest, a pair of foot-rest, and a pair of skirts to provide seat posture positioning functions. P27 power wheelchair maximum weight capacity is 265 lbs (120kg). Maximum speed is 3.75 mph (6 kph). The device can be disassembled for transport and is provided with an external battery charger. ### Performance Testing: - 1) EMC Report ANSI / RESNA WC/Vol.2: 2009 (Section 21), 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. {5}------------------------------------------------ - 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. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo with a purple butterfly-like design against a blue square background. To the left of the butterfly is a thin yellow line with a circle at the top. Below the butterfly and line is the word "HEARTWA" in bold, black letters. ## 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 പ E-mail : sales@heartway.com.tw 20 Image /page/6/Picture/4 description: The image contains two logos. The top logo is for "TUV CERT" and features the letters "TUV" stacked on top of the word "CERT" inside of a circular design. The bottom logo is for "ISO-9001 CERTIFICATED" and features the text inside of a rounded rectangle. P #### COMPARISON TABLE | ITEMS | PREDICATE<br>DEVICE | SUBJECT<br>DEVICE | Safety and<br>effectiveness of<br>subject device<br>compared to the<br>predicate device | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Brand name | HEARTWAY | HEARTWAY | Same brand | | Manufacturer | HEARTWAY Medical<br>Products Co., Ltd. | | Same manufacture | | Series | Power Tilt Seating<br>System power chair | Electrically Powered<br>Wheelchair | Different design | | Model | P16RT | P27 | Different models | | 510K number | K070489 | K142783 | Different<br>submissions | | Similarities | | | | | Intended use | The device is<br>intended for medical<br>purposes to provide<br>mobility to persons<br>restricted to a sitting<br>position. | The device is<br>intended for<br>medical purposes<br>to provide mobility<br>to persons<br>restricted to a<br>sitting position. | Same intended<br>use | | Frame<br>Type<br>Material | Folded<br>Carbon steel alloy | Folded<br>Carbon steel alloy | Same material | | Footplates | ABS | ABS | Same material | | Back<br>upholstery | Fabric | Fabric | Same material | | Armrest<br>types | Flip-backward | Flip-backward | Same type | | Wheel Lock | Push-to-Lock | Push-to-Lock | Same type | | Suspension | Cross brace | Cross brace | Same type | | EARTWAY | | | | | Seat tilting<br>function | Yes | Yes | Same function | | Patient<br>contacting<br>material | Seat PVC material<br>Hand grip PVC material<br>Safety belt PVC material | Seat PVC material<br>Hand grip PVC<br>material<br>Safety belt PVC<br>material | Same material | | Electronic<br>controller | PG VR2 70 Amp | PG VR2 70 Amp | Same controller | | Anti-tipper | Yes | Yes | Same function | | Biocompatibility | ISO 10993-1<br>ISO 10993-5 | ISO 10993-1<br>ISO 10993-5 | Same<br>biocompatibility | | Warranty | 3 years: Main frame<br>1 years: Controller /<br>gear motor / batteries<br>w/o exhaustive and<br>wear parts | 3 years: Main frame<br>1 years: Controller /<br>gear motor /<br>batteries w/o<br>exhaustive and wear<br>parts | Same warranty | | | | Differences | | | Maximum<br>speed | 9.6km/h( 6 mph) | 6 km/h(3.75 mph) | Smaller speed | | Maximum<br>user weight<br>capacities | 500 lbs / 225 kg | 265 lbs/120 kgs | Smaller weight | | Overall<br>dimension<br>Overall length | 1150 mm / 45" | 1030 mm / 40.5" | Smaller Length | | Overall width | 660 mm / 26" | 870-1420 mm<br>/34.2"-55.9" | Larger width | | Overall height | 1170 mm / 46" | 1250 mm / 49.2" | Larger height | | Batteries<br>Quantity<br>Type | Two<br>50Ah 12VDC | Two<br>Same | Same<br>Same type | | Range per<br>charge | 35km / 21.8 miles | 32km / 20 miles | Smaller range | | | | | | | Rear wheels | | | | | Quantities | 2 | 2 | Smaller rear tires | | Sizes/type | 14.0" *3"x 2 | 12.4"x2.16"x2 | | | | (PU solid tire) | (Pneumatic tire) | | | Casters | 9.5" *3" x 2 | 7.48"x1.77"x2 | Smaller castors | | | (PU solid tire) | (PU solid tire) | | | Seat size | | | | | Width | 66 cm / 25.9" | 46 cm / 18" | Smaller seat width | | Depth | 87 cm / 34.2" | 47 cm / 18.5" | & depth | | Height | 41 cm / 16.1" | 49-60cm / | Larger seat | | | | 19.3"-23.6" | height | | Backrest<br>reclining<br>function | No | Yes | Smaller incline<br>angle | | Curb<br>climbing | 65 mm/2.5" | 50 mm/1.96" | Smaller curb | | Dynamic<br>incline angle | 12 degrees | 6 degrees | Smaller incline<br>angle | | Ground<br>clearance | 80 mm/3.15" | 50 mm/1.96" | Smaller clearance | | Turning<br>radius | 610mm/24" | 730 mm/28.7" | Larger turning<br>radius | | Motor<br>Quantity<br>Type | 2<br>24V, 500W | 2<br>24V, 200W | Same<br>Smaller power | | Wheelchair | w/ batteries | w/ batteries | 53 lbs frame | | Weight | 114kg / 251 lbs | 90 kgs / 198 lbs | difference | | | w/o batteries | w/o batteries | | | | 84kgs /185 lbs | 60 kgs / 132 lbs | | | Charger | 24VDC | 24VDC | Different | | | (UL 1310 ) | (UL E201162) | UL -certified<br>chargers | {7}------------------------------------------------ Image /page/7/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. The word HEARTWAY is written in bold, black letters below the square. # 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 പ 60 Image /page/7/Picture/3 description: The image contains two logos. The first logo is the "TÜV CERT" logo, which is a blue circle with the letters "TÜV" in the center. The second logo is a rounded rectangle with the text "ISO-9001 CERTIFICATED" inside. Both logos appear to be certification marks. E-mail : sales@heartway.com.tw {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows a logo with a purple butterfly-like design on a blue square. To the left of the square is a yellow line with a circle at the top. Below the square is the word "HEARTWAY" in black, block letters. The background is white. ## HEARTWAY MEDICAL PRODUCTS CO.,LTD. TÜV-FREE 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 60 Image /page/8/Picture/3 description: The image shows the email address "sales@heartway.com.tw". The email address is preceded by the text "E-mail :". The email address is likely for sales inquiries related to the company Heartway. The domain name suggests that the company is located in Taiwan. 20 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows a logo with a purple butterfly-like shape inside a blue square. The word "HEARTWA" is written in black letters below the square. A yellow line with a circle at the top is on the left side of the image. EARTWAY MEDICAL PRODUCTS O #### COMPARISON DISCUSSION For the maximum user weight capacity, wheelchair total weights, cruise range per charging and maximum speed, the subject device are smaller than the predicate device. The facts show the subject device is designed to perform in a lighter weight way than the predicate device. In order to function in a lighter weight design, rear wheels sizes and front castors sizes of the subject device can be smaller than those of the predicate device. To drive a lighter wheelchair with a slower maximum speed, the motor powers of the subject device can be smaller than those of the predicate device, based on the work-energy theorem. Since the motor powers and the maximum speed of the subject device are smaller than those of the predicate device, the cruise range is smaller according to the definition of work. These differences are only related to the designing aspects and not related to the safety and effectiveness aspects. Owing to the 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 larger overall width of the subject device. But the subject device passes the ISO 7176 series standards, the static and dynamic stabilities are all assured. Thus different radius and different widths do not raise any safety and effectiveness aspects. They are substantially equivalent. The overall height and seat height of the subject device are larger than those of the predicate device. The subject device performs in a lighter weight design and has a backrest reclining function and a less maximum user weight capacity, the center of gravity of the subject device is higher than that of the predicate device. The fact results in smaller incline angle of the subject device 6 degrees, compared with 12 degrees of the predicate device. After all, two devices all pass the ISO 7176-2 standard; the dynamic stabilities of two devices are all assured. And this 6 degrees limitation is shown in the P27 user's manual for safety operation. There are no safety and effectiveness concerns. They are substantially equivalent with respect to these differences. The battery chargers are different model 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 aspects concerned. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image is a business card for HEARTWAY MEDICAL PRODUCTS CO.,LTD. The card includes the company's logo, address, phone number (886-4-23580357), fax number (886-4-23590786), website (www.heartway.com.tw), and email address (sales@heartway.com.tw). The card also includes the TÜV CERT and ISO-9001 CERTIFICATED logos. 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 P27, is as safe and effective as, and functions in a manner equivalent to the K070489 predicate device, HEARTWAY Power Tilt Seating System power chair P16RT. 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.