VALENTINE STEEL WHEELCHAIR

{0}------------------------------------------------ valentine international Lu. 詠 立 實 業有限公司 E-mail : info@valentine-dynalife.com.tw http : // www.valentine-dynalife.com Tel:886-2-8692-6662 Fax:886-2-8692-6660 # " 510(k) SUMMARY" ## MAY 2 8 2014 # K130017 Submitter's Name: Valentine International Ltd. 8F, No. 149, Sec. 2, Ta Tung Rd., Hsichih District, New Taipei City, 221, Taiwan, R.O.C. Date of summary prepared: December 31, 2013 Device Name: Valentine Steel Wheelchair, model: 1000 Proprietary Name: Mechanical Wheelchair Common or Usual Name: Classification Name: Mechanical Wheelchair, Class 1, 21 CFR 890.3850 510K contact person for all correspondence Dr. Jen. Ke-Min Tel: 886-3-5208829 Fax: 886-3-5209783 Email: ceirs.jen@msa.hinet.net Indications for Use: The device is intended for medical purpose to provide mobility to persons restricted to a sitting position. Description of the device: The Valentine Steel Wheelchair, model: 1000 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transportation and it is foldable easily. The device is consistent with the ISO 7176 series standards and uses a standard sling type back and seat, and the upholstery fabric meets the flame retardant test. The maximum weight bearing capacity of the device is 250 lbs/113.5 kgs. The following surfaces are recommended not to operate on: - Sand surface - Wet or icy surface . - Road maintenance hole metal cover ● - Multiple steps. - Escalators. ( Use the elevator.) - Steep incline over 10 degrees. - . Ground clearance over 60 mm / 2.3" - Curb climbing ability over 20 mm / 0.8" {1}------------------------------------------------ 立實業有限公司 ફંગ્રે E-mail : info@valentine-dynalife.com.tw http : // www.valentine-dynalife.com Legally marketed device for substantial equivalence comparison: Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816) Performance Testing: Valentine Steel Wheelchair, model: 1000 meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. Technological Characteristics Summary: To ensure the safety and effectiveness of the following ISO standards were complied with: - ISO7176-1:1999, Wheelchairs - Part 1: Determination of Static Stability. - ISO7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes. . - ISO7176-5: 2008, Wheelchairs Part 5: Determination of overall dimensions, ● mass and maneuvering space. - ISO7176-7: 1998, Wheelchairs Part 7: Measurement of seating and wheel . dimensions. - . ISO7176-8: 1998, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths. - . ISO7176-11:2012, Wheelchairs - Part 11: Test dummies. - ISO7176-13:1989, Wheelchairs Part 13: Determination of coefficient of friction ● of test surfaces. - ISO7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, . documentation and labelling. - ISO7176-16:2012, Wheelchairs Part 16: Resistance to ignition of upholstered ● parts. Requirements and test methods. Discussion of Clinical Testing Performed: NA {2}------------------------------------------------ valentine · international · Ltd. 詠 立 實 業 有 限 公 司 E-mail : info@valentine-dynalife.com.tw http : // www.valentine-dynalife.com Tel:886-2-8692-6662 Fax:886-2-8692-6660 | Comparison Table between the subject device and predicate device: | | | | | |--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------|--|--| | | | | | | | ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | | | | BRAND NAME | Zhenjiang Assure | Valentine | | | | MANUFACTURER | Zhenjiang Assure Medical<br>Equipment Co., Ltd. | Valentine<br>International Ltd. | | | | MODEL NO | Mechanical Wheelchair, A227 | Steel Wheelchair,<br>model 1000 | | | | 510K NO | K112816 | K130017 | | | | INTENDED USE | The device is intended for medical<br>purposes to provide mobility to<br>persons restricted to a sitting<br>position. | Same | | | | OPERATING | Indoor / outdoor wheelchair | Same | | | | TECHNOLOGICAL<br>CHARACTERISTICS | According to ISO<br>7176-1/-3/-5/-7/-8/-11/-13/-15/-16<br>series standards | Same | | | | FRAME<br>Seat width<br>Cross brace<br>Seat height<br>Backrest height<br>Reclining backrest<br>Seat sling<br>Frame colors | 18"<br>YES<br>20"<br>un-adjustable<br>fixed<br>padded nylon<br>Blue | Same | | | | ARMREST<br>Arm pad<br>Flip back<br>Height-adjustable | Padded<br>YES, detachable<br>Pre-installed armrests | Same | | | | 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>10~150 | Same | | | | REAR AXLE<br>Offset axle<br>Quick-release axle | YES<br>YES | Same | | | D3 {3}------------------------------------------------ ### valentine international Luc. 詠 立實業有限公司 E-mail : info@valentine-dynalife.com.tw http : // www.valentine-dynalife.com Tel:886-2-8692-6662 Fax:886-2-8692-6660 | ITEMS | PREDICATE DEVICE | SUBJECT DEVICE | |---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------| | REAR WHEEL<br>Size<br>Tire type<br>Handrim material | 24"<br>PU solid material<br>Steel composite | Same | | CASTERS<br>Size<br>Tire type | 8"<br>PU solid material | Same | | WHEEL LOCK | Pull-to-Lock | Same | | WEIGHT CAPACITY | 250 lbs/113.5 kgs | Same | | WEIGHT OF CHAIR | 40 lbs / 18.2 kgs | Same | | WARRANTY | 12 months for the main parts<br>(The chair side frames are<br>guaranteed for 5 years from the date<br>of purchase. ) | Same | | ACCESSORIES<br>Anti-tipper<br>Rear stepper<br>Fold down push<br>handle<br>Safety belt | YES<br>YES<br>YES<br>Optional | NO<br>YES<br>YES<br>Optional | ※ Actually, the subject device is identical to and transferred from the predicate device. Substantial equivalence comparison discussion: Actually, the subject device is identical to and transferred from the predicate device. From the above comparison table the intended uses between the subject device: Valentine Steel Wheelchair, model: 1000 and the predicate device: Zhenjiang Assure Mechanical Wheelchair, model: A227 (K112816) are the same. Mainframes of two devices are foldable. There are similar removable desk-length armrest and same swing-away detachable elevating footrest. Besides, back upholstery material is also the same resistance-ignitability fabric and also meets the requirements for flame retardant. The differences in the overall appearance do not raise any safety or effectiveness aspect. Thus the subject device is substantially equivalent to the predicate device. D4 {4}------------------------------------------------ Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 28, 2014 Valentine International, Limited Dr. Jen. Ke-Min 8F, No. 149, Sec. 2, Ta Tung Rd., Hsichih District - New Taipei City 221 Taiwan. R.O.C. Re: K130017 Trade/Device Name: Valentine Steel Wheelchair, model: 1000 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 6, 2014 Received: April 15, 2014 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, 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 or any I 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 {5}------------------------------------------------ Page 2 - Dr. Jen. Ke-Min 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, # Felipe Aquel -S Carlos Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K130017 #### Device Name Valentine Steel Wheelchair, model: 1000 #### Indications for Use (Describe) The device is intended for medical purpose 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) # ം Date: 2014.05.28 17:26:40 > -04'00' 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. 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