SUNTEC Mechanical Wheelchair, model ST-WL-1000

{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 stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 3, 2016 Danyang Suntec Auto Parts Co., Ltd. Jen Ke-Min Official Correspondent Jiepai Industrial Zone, Jiepai, Danyang Zhenjiang, 212300 CHINA Re: K152878 Trade/Device Name: SUNTEC Mechanical Wheelchair, Model ST-WL-1000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 8, 2015 Received: December 16, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 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 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) K152878 Device Name SUNTEC Mechanical Wheelchair, model ST-WL-1000 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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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 word "SUNTEC" in a blue, sans-serif font. The word is centered within a blue oval. The background is white. DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com ## SECTION D 510(k) Summary of Safety and Effectiveness {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the word "SUNTEC" in large, bold, dark blue letters. The word is centered inside of a white oval with a dark blue border. The oval is oriented horizontally. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com ## 510(k) SUMMARY of Safety and Effectiveness Submitter's Name: DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China | Date Summary Prepared: | January 24, 2016 | |-------------------------|--------------------------------------------------| | Proprietary Name: | SUNTEC Mechanical Wheelchair, model ST-WL-1000 | | Common or Usual Name: | Mechanical Wheelchair | | Classification Name: | Mechanical Wheelchair, Class I, 21 CFR 890.3850 | | Product Code: | IOR | | Official Correspondent: | Dr. Jen, Ke-Min | | | Email: ceirs.jen@msa.hinet.net | | | TEL: +886-3-5208829 | | | FAX: +886-3-5209783 | | Predicate Device | Valentine International Ltd. | | | Valentine Steel Wheelchair, model 1000 (K130017) | Indications For Use: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "SUNTEC" in a bold, dark blue font. The word is enclosed in a dark blue oval. The background of the image is white. DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com ### Description of the device: The SUNTEC Mechanical Wheelchair, model ST-WL-1000 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 Requirements of Section E, Part I for Upholstery Fabrics of California Technical Bulletin CAL 117: 2000 standard for flame retardance. Following are features for the ST-WL-1000 - Foldable wheelchair frame, lift up backrest handles and strap into place. - Handy pocket for transporting lightweight items. - One button easy release wheels. Due to the features of the body structure, the rear two wheels can always contact the surface, and the vehicle can be operated 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 - Avoid going up multiple steps. - Avoid using escalators. Use the elevator. - . Too steep incline over 10 degrees. - . Turning diameter: 31" / 785 mm - Ground clearance: 2.3" /58.4 mm - Curb climbing ability: 0.8" / 20.3 mm {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SUNTEC" in bold, dark blue letters. The word is centered inside a white oval with a dark blue border. The oval is oriented horizontally and takes up most of the frame. DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com ### Performance Testing: - 1) ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 1999. (FDA Recognition Number: 16-158 ) - 2) ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012. (FDA Recognition Number: 16-192) - 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) {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "SUNTEC" in a blue, bold, serif font. The word is centered inside a blue oval. The background is white. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com ### COMPARISON TABLE | Comparison items | Predicate device<br>(K130017) | Subject device<br>(K152878) | Pose any change in safety or<br>effectiveness, compared with the<br>predicate device? | |-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------| | BRAND NAME | Valentine | SUNTEC | There is no change in safety or<br>effectiveness. | | MANUFACTURER | Valentine International<br>Ltd. | DANYANG SUNTEC<br>Auto Parts Co., Ltd. | There is no change in safety or<br>effectiveness. | | MODEL NO | Steel Wheelchair, model<br>1000 | Mechanical Wheelchair,<br>model ST-WL-1000 | There is no change in safety or<br>effectiveness. | | 510(k) No. | K130017 | K152878 | There is no change in safety or<br>effectiveness. | | Similarities | | | | | INTENDED USE | The device is intended<br>for medical purposes to<br>provide mobility to<br>persons restricted to a<br>sitting position. | Same intended use | There is no change in safety or<br>effectiveness. | | OPERATING<br>ENVIRONMENTS | For Indoor / Outdoor use | Same operating<br>environments | There is no change in safety or<br>effectiveness. | | TECHNOLOGICAL<br>CHARACTERISTICS | According to ISO<br>7176-1/-3/-5/-7/-8/-11/-1<br>3/ -15/-16 series<br>standards | Same technological<br>characteristics | There is no change in safety or<br>effectiveness. | | Overall dimensions<br>Length<br>Width<br>Height | 42"<br>25.2"<br>36.2" | Same overall<br>dimensions | There is no change in safety or<br>effectiveness. | | Seat dimensions<br>Length<br>Height<br>Width | 18"<br>20"<br>18" | 18"<br>20"<br>17.3" - 18.1" | There is no change in safety or<br>effectiveness. | | FRAME<br>Cross brace<br>Backrest height<br>Reclining backrest<br>Seat sling | YES<br>Un-adjustable<br>fixed<br>Padded Nylon | Same frame | There is no change in safety or<br>effectiveness. | | ARMREST | | | There is no change in safety or effectiveness. | | Arm pad | Padded | Same armrest | | | Flip back | YES, detachable | | | | Height-adjustable | Pre-installed armrests | | | | HANGERS | | | There is no change in safety or effectiveness. | | Swing-away | YES | Same hangers | | | Elevating leg rest | YES | | | | Articulating leg rest | YES | | | | Footplate style | Padded | | | | Heel loop | No | | | | Footrest angle | 10~15° | | | | ACCESSORIES | | | There is no change in safety or effectiveness. | | Anti-tipper | YES | YES | | | Fold down push handle | YES | YES | | | Seat belt | Optional | Optional | | | REAR AXLE | | | There is no change in safety or effectiveness. | | Offset axle | YES | Same rear axle | | | Quick-release axle | YES | | | | REAR WHEEL | | | There is no change in safety or effectiveness. | | Size | 24" * 1" | Same size | | | Tire type | PU Solid Material | Same tire type | | | Wheel Lock | Pull-to-Lock | Same wheel lock | There is no change in safety or effectiveness. | | Ground Clearance | 2.3" / 58.4 mm | Same ground clearance | There is no change in safety or effectiveness. | | Climbing Angle | 10 degrees | Same climbing angle | There is no change in safety or effectiveness. | | Curb climbing ability | 0.8"/ 20 mm | Same curb climbing ability | There is no change in safety or effectiveness. | | Minimum turning diameter | 31" / 785 mm | Same turning diameter | There is no change in safety or effectiveness. | | Differences | | | | | Weight Capacity | 250 lbs. /113.4 kg | 220 lbs. / 100 kg | The users will maneuver the wheelchair<br>more easily for a lighter wheelchair. | | Casters | | | PVC material will endure for a longer | | Size | 8"*1" | Same size | period than PU material. There is no<br>change in safety or effectiveness. | | Tire type | PU solid material | PVC solid material | | | Handrim Diameter<br>/material | 22" / Steel Composite | 19.8" / Steel Composite | 10% smaller in handrim diameter is not<br>related for a change in safety or<br>effectiveness. | | Weight of Chair | 39.6 lb / 18 kg | 38.5 lb / 17.5 kg | 2.7% lighter in total mass will make the<br>user or attendant more easily maneuver<br>the wheelchair. | | Warranty | | | | | 12 months for the main parts (footrest, wheel lock, armrest, cross braces, backrest canes, front fork, fork stem house) | 12 months for the main part (footrest, wheel locks, armrest, cross braces, backrest canes, front fork, fork stem house). | The 2 years less guarantee period for chair side frames will make the user pay more money and it is not to do with the change in safety or effectiveness. | | | The chair side frames are guaranteed 5 years from the date of purchase. | The chair side frames are guaranteed 3 years from the date of purchase. | | | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "SUNTEC" in a dark blue, serif font. The word is centered within a white oval with a thin, dark blue border. The background of the image is white. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "SUNTEC" in a blue, sans-serif font. The word is centered within a blue oval. The background is white. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com ISO 7176-5:2008 #### Wheelchairs - Part 5: Determination of overall dimensions, mass and maneuvering space | Full overall length | 41" / 1050 mm | Same overall length | There is no change in safety or<br>effectiveness. | |----------------------------------------------------------------------------------------------|-----------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Overall width | 25" / 640 mm | Same overall width | There is no change in safety or<br>effectiveness. | | Handgrip height | 36" / 920 mm | 29" / 740 mm | 19.5% lower in handgrip height will<br>cause some uncomforting to a taller<br>person and she/he may bow their waist<br>to hold the wheelchair.<br>As long as the attendant's height is not<br>too large, a normal person will not feel<br>uncomfortable (or to bow his/her waist)<br>to hold the handgrip. There is no<br>change in safety or effectiveness. | | Stowage length | 42" / 1066 mm | 35.4" / 900 mm | Shorter stowage length means the<br>device can fit the limited width space | | Stowage width | 11.4" / 290 mm | 14.5" / 370mm | of the more vehicles, leading to more | | Stowage height | 36.2" / 915 nm | 36.2" / 915 mm | convenience, and larger stowage width<br>means you cannot stack more stuff on<br>the wheelchair. There is nothing to do<br>with the safety and effectiveness<br>concerns. | | Total mass | 39.6 lb / 18 kg | 38.5 lb / 17.5 kg | 2.7% lighter in total mass will make<br>the user or attendant more easily<br>maneuver the wheelchair. | | Mass of heaviest part | 39.6 lb / 18 kg | 25.5 lb / 11.7 kg | Lighter mass will make the user or<br>attendant easier to maneuver the<br>wheelchair. | | Ground clearance | 2.3" / 58.4 mm | Same ground clearance | There is no change in safety or<br>effectiveness. | | Required width of angled<br>corridor | 35.8" / 910 mm | 34.4" / 875 mm | 3.8% less in angled corridor width has<br>nothing to do with safety or<br>effectiveness. | | Required doorway entry<br>depth | 52" / 1320 mm | 59" / 1500 mm | 13.6% larger in depth may bring some<br>inconvenience, but we have<br>recommended users to "ALWAYS ASK<br>FOR HELP". There is no change in<br>safety or effectiveness. | | Required corridor width<br>for side opening | 37.4" / 950 mm | 28.5" / 725 mm | 23.6% narrower in required corridor<br>width will let the user move more<br>easily in the narrower space. | | ISO 7176-7:1998 | | | | | Wheelchairs - Part 7: Determination of seating dimensions - Definitions and measuring method | | | | | Seat plane angle | 3.8° | 4° | 5.3 % larger in seat plane angle cannot<br>pose any change in safety or<br>effectiveness. | | Effective seat depth | 20"/514 mm | 16.9"/430 mm | 16% less in effective seat depth may<br>bring less free space for adjustment,<br>but there is no change in safety or<br>effectiveness. | | Seat width | 16.5"/420 mm | 17.3" - 18.1" /<br>440-460 mm | Larger seat width lets users feel more<br>comfortable.<br>There is no change in safety or<br>effectiveness. | | Effective seat width | 19.3" / 490 mm | 17.3"- 17.5"/<br>440 - 445 mm | Less effective seat width means not to<br>pose a change in safety or<br>effectiveness. | | Seat surface height at<br>front edge | 19.2"/488 mm | 18.9"/480 mm | 1.6% lower in seat surface height has a<br>negligible difference and will not pose<br>a change in safety or effectiveness. | | Backrest angle | 8.4° | 10° | 19% larger in backrest angle can bring<br>a more comfortable feeling to the user<br>and there is no change in safety or<br>effectiveness since it passes static and<br>dynamic stabilities tests. | | Backrest height | 17.2"/439 mm | 16.9"/430 mm | 2% less in backrest height is negligible<br>for posing a change of safety or<br>effectiveness. | | Backrest width | 16.1"/410 mm | 18.1"/460 mm | 12% larger in backrest width will bring<br>more space for user to load the body.<br>There is no change in safety or<br>effectiveness. | | Footrest-to-seat | 14.3"/365 mm | 16.5"/420 mm | 15% longer in footrest-to-seat will<br>make the wheelchair easily load a taller<br>person. There is no change in safety or<br>effectiveness. | | Footrest clearance | 5.8"/148 mm | 6.7"/170 mm | 14.8% higher in footrest clearance will<br>make the wheelchair more easily<br>overcome an obstacle and there is no<br>change in safety or effectiveness. | | Footrest length | 7.2"/184 mm | 5.9"/150 mm | 18.7% shorter in footrest length will<br>not make a change in safety or<br>effectiveness since 150 mm in footrest<br>length can easily hold a foot of a<br>normal person. | | Footrest-to-leg angle | 94.6° | 90° | 4.8% smaller in footrest-to-leg angle is<br>negligible to pose a change in safety or<br>effectiveness. | | | | | effectiveness. | | Leg-to-seat-surface angle | 91.6° | 97° | 5.8% larger in leg-to-seat-surface angle<br>is negligible to pose a change in safety<br>or effectiveness. | | Armrest height | 9.5"/242 mm | 10.2"/260 mm | 7.4% larger in armrest height will not<br>pose a change in safety or<br>effectiveness. | | Front-of-armrest to<br>backrest | 14"/358 mm | 11.4"/290 mm | 18.9% less distance in Front-of-armrest<br>to backrest will let the user feel limited<br>in space but will not pose a change in<br>safety or effectiveness. | | Armrest length | 10.2"/260 mm | Same length | There is no change in safety or<br>effectiveness. | | Armrest width | 21.6"/550 mm | Same width | There is no change in safety or<br>effectiveness. | | Armrest angle | 4.8° | 4° | 16.6% smaller in armrest angle is<br>related to the arm feeling, not related to<br>the safety or effectiveness. | | Distance between<br>armrests | 18.2"/463 mm | 18.1"/460 mm | 0.64% shorter in distance between<br>armrests does not pose a change in<br>safety or effectiveness. | | Front location of armrest<br>structure | 13.9"/355 mm | 11"/280 mm | 21% less in front location of armrest<br>structure will not pose a change in<br>safety or effectiveness since 280 mm<br>can provide an enough holding space. | | Handrim diameter | 21.4"/546 mm | 19.8"/505 mm | 7.6% smaller in Handrim diameter is<br>not related to a change in safety or<br>effectiveness. | | Propelling wheel<br>diameter | 24"/612 mm | 23.6"/600 mm | 1.9% smaller in propelling wheel<br>diameter has nothing to do with a<br>change in safety or effectiveness. | | Horizontal location of<br>axle | 2"/53 mm | 1.18"/ 30 mm | 43.4% shorter in Horizontal location of<br>axle has nothing to do with the safety<br>or effectiveness. | | Vertical location of axle | 3.9"/101 mm | 7"/180 mm | 78% larger in Vertical displacement of<br>wheel axle has nothing to do with the<br>safety or effectiveness. | | Castor wheel diameter | 7.5"/191 mm | 7.8"/200 mm | 4.7% larger in castor wheel diameter<br>can provide more capability to move<br>on the road, but it is not to pose a<br>change in safety or effectiveness. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "SUNTEC" in a dark blue, sans-serif font. The word is centered within a white oval shape that is outlined with a thin, dark blue border. The background of the image is white. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the word "SUNTEC" in a dark blue, sans-serif font. The word is centered inside a white oval with a thin, dark blue border. The oval is oriented horizontally. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "SUNTEC" in a bold, dark blue font. The word is centered inside a white oval with a thin, dark blue border. The oval is oriented horizontally. DANYANG SUNTEC AUTO PARTS CO., LTD. Jiepai Industrial Zone, Jiepai, Danyang, Zhenjiang, Jiangsu Province, 212300 China TEL: 86-511-86380900/ 86370815 FAX:86-511-86380182 Email:dysuntec@hotmail.com #### COMPARISON DISCUSSION From the above comparison table, we know that the intended uses of the subject device and the predicate device are the same. Mainframes of two devices are foldable. Removable desk-length armrest and the swing-away detachable elevating footrest are the same. Besides, back upholstery material is the same resistance-ignitability fabric and also meets the requirements for flame retardant. The minor differences in the castor tire type (PU vs. PVC) and the weight of chair (39.6 lb vs. 38.5 lb) do not raise any safety and effectiveness concerns or changes. The tire sizes are indicated on the product durable label. Thus the same safety level for the two devices is assured. At last, the chair side frames are guaranteed for 5 years from the date of purchase for predicate device and 3 years for the subject device. The difference is related with the more cost paid by the user for the chair side frames and does not raise any safety and effectiveness concerns. Despite of the differences above and shown in the ISO 7176-5: 2008 and ISO 7176-7:1998 comparison table, the subject devices completed the performance tests in accordance with ISO 7176 series standards. They function safely and effectively. There are no safety or effectiveness concerns. #### CONCLUSIONS From the comparison table, we know that the subject device is as safe and effective as, and functions in a manner equivalent to the predicate device. The conclusions drawn from the non-clinical tests demonstrate that the device is 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.