SUNCO Mechanical Wheelchair, model SKW-9003

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 20, 2016 Danyang Sunco Machinery Co., Ltd Jen Ke-Min Official Correspondent Taojing Road, Optics Industrial Park, Situ Town Danyang City, 212300 CN Re: K153328 Trade/Device Name: SUNCO Mechanical Wheelchair, model SKW-9003 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 4. 2016 Received: July 11, 2016 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 {1}------------------------------------------------ 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/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 -A - 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) K153328 #### Device Name SUNCO Mechanical Wheelchair, model SKW-9003 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}------------------------------------------------ Taojing Road, Optics Industrial Park, Situ Town, Danyang City, Jiangsu, China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116 ## SECTION D ## 510(k) Summary of Safety and Effectiveness (per 21 CFR 807.92) {4}------------------------------------------------ Taojing Road, Optics Industrial Park, Situ Town, Danvang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116 #### I. SUBMITTER Danyang Sunco Machinery Co., Ltd. Taojing Road, Optics Industrial Park, Situ Town, Danyang City, Jiangsu, China 212300 Phone: +86-511-86733686 Fax: +86-511-86733116 Contact Person: Jen, Ke-Min, ceirs.jen(@msa.hinet.net Date Prepared: July 20, 2016 #### DEVICE II. | Name of Device: | SUNCO Mechanical Wheelchair, model SKW-9003 | |-----------------------|---------------------------------------------| | Common or Usual Name: | Mechanical Wheelchair | | Classification Name: | Wheelchair, Mechanical (21 CFR 890.3850) | | Regulatory Class: | Class I | | Product Code: | IOR | ### III. PREDICATE DEVICE Valentine International Ltd. Valentine Steel Wheelchair, model 1000, K130017 ### IV. DEVICE DESCRIPTION The SUNCO Mechanical Wheelchair, model SKW-9003 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, and the upholstery fabric meets the EN 1021-1:2006 Furniture --Assessment of ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette & EN 1021-2:2006 Furniture -- Assessment of ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent {5}------------------------------------------------ Taojing Road, Optics Industrial Park, Situ Town, Danyang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116 The features of the subject device include - The back upholstery material is resistance-ignitability fabric. - ������������������������������������������������������������������������������������������������������������������������������������������������������������������������������ The removable desk-length armrest and swing-away detachable footrest.. Due to the device design of the body structure the following surfaces are recommended NOT to operate on: - . Sand surface - . 1Wet or icy surface - . Road maintenance hole metal cover - . Avoid going up multiple steps. - . Avoid using escalators. Use the elevator. - . Too steep incline over 10 degrees. - . Turning Diameter 31" - Ground clearance: 2.3" . - . Curb climbing ability: 0.8" #### v. INDICATIONS FOR USE The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE - Comparison table | ITEMS | Predicate device | Subject device | |---------------|---------------------------------|------------------------------------------| | Manufacturer | Valentine International Ltd. | DANYANG SUNCO<br>Machinery Co., Ltd. | | Brand name | Valentine | SUNCO | | Device name | Steel Wheelchair,<br>model 1000 | Mechanical Wheelchair,<br>model SKW-9003 | | 510(k) Number | K130017 | K153328 | {6}------------------------------------------------ Taojing Road, Optics Industrial Park, Situ Town, | Similarities | | | |------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | The device is intended for<br>medical purposes to provide<br>mobility to persons<br>restricted to a sitting<br>position. | Same indications for use | | Operating environments | For Indoor / Outdoor use | Same operating environments | | Technological<br>characteristics | Testing per ISO<br>7176-1/-3/-5/-7/-8/-11/-13/<br>-15/-16 series standards | Same technological standards | | Overall dimensions<br>Length<br>Width<br>Height | 42"<br>25.2"<br>36.2" | 42"<br>25.2"<br>36" | | FRAME<br>Cross brace<br>Backrest height<br>Reclining backrest<br>Seat sling<br>Frame color | YES<br>Fixed<br>Fixed<br>Padded Nylon<br>Blue Powder Coating | YES<br>Fixed<br>Fixed<br>Padded Nylon<br>Silver hammer tone | | HANGERS<br>Swing-away<br>Elevating leg rest<br>Articulating leg rest<br>Footplate style<br>Heel loop<br>Footrest angle | YES<br>YES<br>YES<br>Padded<br>No<br>10~15° | Same hangers | | REAR AXLE<br>Offset axle<br>Quick-release axle | YES<br>YES | Same rear axle | | REAR WHEEL<br>Size<br>Tire type<br>Handrim Diameter /<br>material | 24"*1"<br>PU Solid Material<br>21" / Steel Composite | Same rear wheel | | Wheel Lock | Pull-to-Lock | Same wheel lock | | Ground Clearance | 2.3" | Same ground clearance | | Climbing Angle | 10 degrees | Same climbing angel | | Curb climbing ability | 0.8" | Same curb climbing ability | | Minimum turning<br>diameter | 31" | Same minimum turning radius | | Curb Stepper | YES | YES | | ARMREST | | | | Arm pad | Padded | Padded | | Flip back | YES | YES | | Height-adjustable | NO | NO | | Optional accessory | | | | Anti-tipper | YES | YES | | Seat belt | YES | YES | | Differences | | | | Seat dimensions | | | | Depth | 16" | 16" | | Height | 20" | 20" | | Width | 18" | 20" | | Casters | | | | Size | 8"*1" | 7.9"*1" | | Tire type | PU solid material | PVC solid material | | Weight of wheelchair | 40 lb / 18.1 kg | 38.6 lb / 17.5 kg | | Weight Capacity | 250 lb / 113.4 kg | 220 lb / 100 kg | | Warranty | 12 months for the main parts<br>(footrest, wheel locks, armrest,<br>cross braces, backrest canes,<br>front fork, fork stem house)<br>The chair side frames are<br>guaranteed for 5 years from the<br>date of purchase. | 12 months for the main parts<br>(chair side frames, footrest, wheel<br>locks, armrest, cross braces,<br>backrest canes/Push handle tube,<br>front fork, fork stem house) | {7}------------------------------------------------ Taojing Road, Optics Industrial Park, Situ Town, Danyang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116 #### ● Discussion From the above comparison table, we knew that the indications for use of both devices are the same. Both mainframes of two devices are foldable. The castor tires are PU 8" solid tires for predicate device and PVC 7.9" solid tires for subject device. The PU tires can absorb more vibrational impact from the unsmooth ground than PVC tires. The difference is not much as to raise any safety and effectiveness concerns. The weights of wheelchairs (40 lb vs. 38.6 lb) differ not so much to raise any safety and effectiveness concerns. This difference means the user needs less power to move the wheelchair for the subject device. The front/rear tire sizes PVC solid 7.9"*1"/ PU solid 24"*1" and weight capacity (220 lbs.) are indicated on the product durable label and user manual for the {8}------------------------------------------------ Taojing Road, Optics Industrial Park, Situ Town. Danvang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116 subject device. The users can be informed of those limitations. The chair side frames are guaranteed for 5 years for predicate device and 1 year for the subject device. The difference in the chair side frames warranty periods just involves the more cost paid by the users of the subject device, and it does not raise any safety and effectiveness concerns. Overall dimensions are the same, and seat width has the difference of 2". No safety and effectiveness concerns are raised about this. The other safety and effectiveness concerns of the subject device have been considered and mitigated by complying with the ISO 7176 series standards. ### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ### Biocompatibility testing The biocompatibility evaluation for the SUNCO Mechanical Wheelchair SKW-9003 was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included the following tests: - Cytotoxicity: ISO 10993-5:2009 - Sensitization: ISO 10993-10: 2009 - Irritation .: ISO 10993-10:2009 ### Safety testing To ensure the safety and effectiveness of the device, the following ISO 7176 series standards were complied with: - 1) ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 2014. (FDA Recognition Number: 16-158 ) - 2) ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012. (FDA Recognition Number: 16-192) {9}------------------------------------------------ Taojing Road, Optics Industrial Park, Situ Town, Danvang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116 - 3) ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008. (FDA Recognition Number: 16-163) - 4) ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998. (FDA Recognition Number: NA) - 5) ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs, 2014. (FDA Recognition Number: NA) - 6) ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012. (FDA Recognition Number: 16-190) - 7) ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989. (FDA Recognition Number: 16-25) - 8) ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996. (FDA Recognition Number: 16-27) - 9) ISO 7176-16 Wheelchairs Part 16 Requirements and test methods for resistance to ignition of upholstered parts, 2012. (FDA Recognition Number: 16-191) - 10) ISO 7176-22 Wheelchairs Part 22 Set-up procedures, 2014 (FDA Recognition Number: NA) #### VIII. CONCLUSIONS The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph III of this section. They are substantially equivalent.