Wheelchair

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human profiles. The symbol is composed of three interconnected profiles facing to the right, with flowing lines beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2017 Kunshan Hi-Fortune Health Products Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. LiYuan Town, TongZhou District, Beijing, 101121 CN Re: K163352 Trade/Device Name: Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: June 22, 2017 Received: June 26, 2017 Dear Ray Wang: 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 for http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, William J. Heetderks -S 2017.07.28 13:46:07 -04'00' 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K163552 Device Name Wheelchair 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) × 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 Druq 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." --- EF PSC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ ## 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K163352 - 1. Date of Preparation 06/21/2017 - Sponsor 2. ## Kunshan Hi-Fortune Health Products Co.,Ltd. No. 301,Qinhe Road, Zhangpu Town, Kunshan City, Jiangsu Province, China 215300 Establishment Registration Number: Not yet registered or the Number Contact Person: HongFa Zhi Position: General Manager Tel: +86-512-55195100 Fax: +86-512-55199300 Email: lance@hi-fortune.net - 3. Submission Correspondent Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com {4}------------------------------------------------ - 4. Identification of Proposed Device Trade Name: Wheelchair Common Name: Mechanical Wheelchair Model(s): HM303 Regulatory Information: Classification Name: Wheelchair, Mechanical Classification: I; Product Code: IOR; Regulation Number: 21 CFR 890.3850; Review Panel: Physical Medicine; Intended Use Statement: The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. - Device Description 5. The proposed device, Wheelchair model HM303, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport. The main frame is made of magnesium alloy frame, which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the front end of the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. A folden set is on the frame, under the grips, for folding backrest. {5}------------------------------------------------ #### 6. Identification of Predicate Device Predicate # 510(k) Number: K153328 Product Name: SUNCO Mechanical Wheelchair Manufacturer: Danyang Sunco Machinery Co., Ltd #### Non-Clinical Test Conclusion 7. Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ## Safety Testing ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability. ISO 7176-3:2012 Wheelchairs – Part 3: Determination of effectiveness of brakes. ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and manoeuvring space. ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions. ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths. ISO 7176-11:2012 Wheelchairs - Part 11 Test Dummies ISO 7176-13:1989 Wheelchairs - Part 13 Determination of Coefficient of Friction of Test Surfaces. ISO 7176-15:1996 Wheelchairs – Part 15: Requirements for information disclosure, documentation and labeling. ISO 7176-16:2012 Wheelchairs – Part 16: Resistance to ignition of postural support device. ISO 7176-22:2014 Wheelchairs - Part 22 Set-up Procedures Biocompatibility Performance Cytotoxicity Test Test Method: MTT Method, MEM with 10%FBS extract Test Standard: ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. Test Result: Did not show potential toxicity Skin Sensitization Test Test Method: Guinea Pig Maximization Test, 0.9% Sodium Chloride Injection Extract & Sesame oil Extract Test Standard: ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Test Result: No significant evidence of causing skin sensitization. ### Skin Irritation Test Test Method: 0.9% Sodium Chloride Injection Extract & Sesame oil Extract {6}------------------------------------------------ Test Standard: ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Test Result: Negligible - 8. Clinical Test Conclusion No Clinical Test conducted. {7}------------------------------------------------ ## 9. Substantially Equivalent (SE) Comparison Table 1 General Comparison | ITEM | Proposed Device | Predicate Device | Remark | |--------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------| | Product Code | IOR | IOR | SE | | Regulation No. | 21 CFR 890.3850 | 21 CFR 890.3850 | SE | | Class | 1 | 1 | SE | | Intended Use | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. | SE | | Design<br>Characteristic | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull/Push-to-Lock, Armrest, Backrest, Footpad | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to-Lock, Armrest, Backrest, Footpad | SE | | Operation<br>Environment | For Indoor/Outdoor use | For Indoor/Outdoor use | SE | # Table 2 Performance Comparison | ITEM | Proposed Device | Predicate Device | Remark | |--------------------------|---------------------------------|----------------------------------|----------| | Overall<br>Dimensions | Length: 1137 mm (44.8") | Length: 42" | | | | Width: 680 mm (26.8") | Width:25.2" | Analysis | | | Height: 880 mm (34.6") | Height:36" | | | Rear Wheel | Size: 559 mm (22") | Size: 24" | Analysis | | | Tire Type: Rubber | Tire Type: PU Solid Material | | | | Rim Diameter/Material: 510.7 mm | Rim Diameter/Material: 21"/Steel | | | | (20.1")/Steel Composite | Composite | | | Wheel Lock | Pull-to-Lock, Push-to-Lock | Pull-to-Lock | SE | | Ground Clearance | 64 mm (2.5") | 2.3" | SE | | Min. Turning<br>Diameter | 1915.2 mm (75.4") | 31" | Analysis | | Armrest | Arm pad: Paded | Arm pad: Padded | SE | | | Height-Adjustable: No | Height-Adjustable: No | | | Seat Dimensions | Depth: 420 mm (16.5") | Depth: 16" | | | | Height: 470 mm (18.5") | Height: 20" | Analysis | | | Width: 410 mm (16.1") | Width: 20" | | | Casters | Size: 152 mm (6") | Size: 7.9" | Analysis | | | Tire Type: PU | Tire Type: PU Solid Material | | | Weight of<br>wheelchair | 11.07kg | 38.6lb/17.5kg | Analysis | | Weight Capability | 100kg | 220lb/100kg | SE | Difference Analysis: The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device. {8}------------------------------------------------ | ITEM | Proposed Device | Predicate Device | Remark | |-----------------------|--------------------------------------------|--------------------------------------------|--------| | Performance Test | Comply with ISO | Comply with ISO | SE | | | 7176-1/-3/-5/-7/-8/-15/-16 | 7176-1/-3/-5/-7/-8/-15/-16 | | | Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | SE | | Label and<br>Labeling | Conforms to FDA Regulatory<br>Requirements | Conforms to FDA Regulatory<br>Requirements | SE | Table 3Safety Comparison # 10. Substantially Equivalent (SE) Conclusion Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.