JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of Jiangsu Healthy Way Medical Equipment Co., Ltd. The logo consists of a graphic on the left and the company name in both Chinese and English on the right. The Chinese name is "江苏亚希维医疗器械有限责任公司", and the English name is "JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO., LTD." PAGE 1 OF Z ## 510(k) SUMMARY MAR 2 8 2012 ## K12948 Submitter's Name: Jiangsu Healthy Way Medical Equipment Co., Ltd. Oianjinhe Road, Xinfeng, Danfu District, Zhenjiang, Jiangsu, China, 212141 Date summary prepared: September 23, 2011 Device Name: Jiangsu Healthy Way Aluminum Mechanical Wheelchair Proprietary Name: Mechanical Wheelchair Common or Usual Name: Mechanical Wheelchair, Class I, Classification Name: 21 CFR 890.3850 Regulation Number: IOR Product Code: Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a seated position. Description of the device: The Jiangsu Healthy Way Aluminum Mechanical Wheelchair is 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, the upholstery fabric meets the resistant to ignition source smouldering cigarette, and match flame equivalent. Literature for Performance Testing: Jiangsu Healthy Way Aluminum Mechanical Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair series standards including: - EN 1021-1 /-2 Assessment of the ignition of upholstered furniture, 2006. - · ISO7176-1 Wheelchairs Part 1: Determination of Static Stability, 1999. - ISO7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2003. - ISO7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008. - · ISO7176-7 Wheelchairs Part 7: Measurement of seating and wheel dimensions, 1998. - · ISO7176-8 Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths, 1998. - ISO7176-11 Wheelchairs Part 11: Test dummies, 1992. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with a hand and the letter Y inside of it. To the right of the logo is the company name in Chinese characters, followed by the English translation "JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO., LTD." - . ISO7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989. - · ISO7176-15 Wheelchairs Part 15: Requirements for information disclosure, w documentation and labelling, 1996. - · ISO7176-16 Wheelchairs Part 16: Resistance to ignition of upholstered parts --Requirements and test methods, 1997. - ISO7176-22 Wheelchairs Part 22:Set-up procedures, 2000. . Legally marketed device for substantial equivalence comparison: KAIYANG Aluminum Wheelchair (K101998) Summary for substantial equivalence comparison: From the above comparison table the intended use between the subject device: Jiangsu Healthy Way Aluminum Mechanical Wheelchair and predicate device: KAIYANG Aluminum Wheelchair (K101998) are the same structure which are made by similar Aluminum. Mainframes of two devices are same foldable and same weight capacity. 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 California Technical standard for flame retardant. The overall appearance differences are not safety aspect. Thus the new device is substantially equivalent to the predicate device. Kezi Ten Dr. Jen. Ke-Min Official Correspondent {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Jiangsu Healthy Way Medical Equipment Co., Ltd. % ROC Chinese-European Industrial Research Society Dr. Jen Ke-Min No. 58 Fu Chiun Street Hsin Chu City Taiwan, ROC 30067 MAR 2 8 2012 Re: K112948 Trade/Device Name: Aluminum Mechanical Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I · Product Code: IOR Dated: March 14, 2012 Received: March 21, 2012 Dear Dr. 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 {3}------------------------------------------------ #### Page 2 - Dr. Jen Ke-Min > 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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, cerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use KI12948 510 (K) Number ( If Known ):____ Device Name: Aluminum Mechanical Wheelchair Indications for Use: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-of Surgical, Orthopedic, Page and Restorative Devices K112948 of 1 1 510(k) Number F1 .