Manual Wheelchair, Model A011

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 21, 2021 Ningbo Shenyu Medical Equipment Co., Ltd. % Vivi Shi Technical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, Shanghai 200122 China Re: K201461 Trade/Device Name: Manual Wheelchair, Model A011 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: March 1, 2021 Received: March 5, 2021 Dear Vivi Shi: We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, PhD Assistant Director. Acute Injurv Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201461 Device Name Manual Wheelchair, Model A011 Indications for Use (Describe) The A011 Manual Wheelchair is to provide mobility to persons limited 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}------------------------------------------------ ## 510(K) Summary - K201461 #### I. Submitter Ningbo Shenyu Medical Equipment Co.,Ltd. Address: No.1318 West of Tanjialing Road, Yuyao, Zhejiang, China Contact Person: Zhou Yuefeng Tel: +86- 574-62517777 Email: sales@shenyumedical.com Submission Correspondent: Primary contact: Mrs. Vivi Shi Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: wei.shi@sungoglobal.com Secondary contact: Mr. RaymondLuo Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda .sungo@gmail.com #### II. Device Name of Device: Manual Wheelchair Common Name: Manual Wheelchair Model(s): A011 # Regulatory Information Classification Name: Mechanical Wheelchair Regulatory Class: I Product code: IOR Regulation Number: 890.3850 Review Panel: Physical Medicine #### III. Predicate device: Sichuan AST MedicalEquipment Co., Ltd. AST Model MA012 and MS019 Rehab Wheelchair 510Knumber: K181795 This predicate has not been subject to a design-related recall. #### IV. Device Description A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. {4}------------------------------------------------ Manual Wheelchair A011 is a mechanical wheelchair including four wheels, a Aluminum alloy frame and a textilene upholstery that is flame resistant. A011 has a physical dimension of 1100mm × 660mm × width × height) with the seat itself has a dimension of 480mm × 430mm (depth × width × height). The device has a weight capacity of 136 kilograms, and weighs about 16 kilograms. The color is yellow and black. ## Main Components: Main frame, back upholstery, seat upholstery, handgrip, arm pad, armrest, front wheel, handrim, antitipper, crossbrace, crossbar, side panel, Legrest strap, footplate, Seat belt, brake. - Main materials: Frame, crossbrace, crossbar, armrest, brake: Aluminum, yellow/black coating Handgrip, side panel, handrim, footplate: PVC Seat and back upholstery: Cover is Nylon fabrics, inside with flame resistant foam Armrest pad: flame retardant sponge &PU The device can be operated indoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions. The specification table is as below: | Main dimensions and structural parameters | | | | |---------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------|-------| | Overall dimension | 1100mm (L) X 660mm (W) X 910mm (H) | | | | Folded dimension | 810mm (L) X 320mm (W) X 930mm (H) | | | | Seat width | 475mm | Horizontal angle of seat | 8° | | Seat depth | 420 mm | Backrest angle | 14° | | Seat height from floor | 510mm | Angle of the legrest against the seat surface | 65° | | Distance between armrest and seat | 180 mm | Distance from footrest to seat | 410mm | | Distance between armrests | 500 mm | Front position of armrest structure | 370mm | | Backrest height | 370 mm | Diameter of armrest circle on rear wheels | 530mm | | Footrest height from floor | 145mm | Horizontal position of shaft | 2.5mm | | Weight of the heaviest part<br>(net weight) | 13.5 Kg | | | | Load capacity | 136Kg (300LB) | | | | Specification of front wheels | Ø200mm | | | | Specification of rear wheels | Ø600 mm | | | | Main technical performance | | | | | Wheel landing performance | All wheels except the lifting wheels must land smoothly | | | | Static stability | Vertical forward tilt ≥10°, vertical backward tilt≥10°, and lateral tilt ≥15° | | | | Hill-holding performance | >8° | | | | Sliding offset | <350mm | | | | Minimum turning radius | <850mm | | | | Minimum reversing width | <1500mm | | | #### V. Indications for use {5}------------------------------------------------ The A011 Manual Wheelchair is to provide mobility to persons limited to a sitting position. | Table 1 General Comparison | | | | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Proposed Device | Predicate Device | Results | | 510K Number | NA | K181795 | -- | | Manufacturer | Ningbo Shenyu Medical Equipment<br>Co., Ltd. | Sichuan AST Medical Equipment<br>Co., Ltd. | -- | | Proprietary<br>Name | Manual Wheelchair | AST Model MA012<br>and MS019 Rehab<br>Wheelchair | -- | | Model | A011 | MA012 and MS019 | -- | | Classification | I | I | Same | | Indications for<br>use | The A011 Manual wheelchair is to<br>provide mobility to persons limited<br>to a sitting position. | The AST ModelMA012 and<br>MS019 Rehab Wheelchairs are to<br>provide mobility to persons limited<br>to a sitting position. | Same | | Basic Design | The Aluminum Manual Wheelchair<br>is indoor/outdoor wheelchair thathas<br>a base with four-wheeled with a seat.<br>The device can be disassembled for<br>transport and it is foldable easily. The<br>device uses a standard sling type<br>back and seat.<br>Aluminum frame with yellow/black<br>coating and folding backrest<br>Flip back armrest PU pad<br>Detachable and elevating footrest<br>Front caster PU tires and detachable<br>rear wheel PU tires Nylon cushion<br>cover of back upholstery and seat<br>upholstery. | The AST ModelMA012 and<br>MS019<br>Rehab Wheelchairare manual<br>wheelchairs.<br>They have adjustable armrests, and<br>multiple axle position. The casters<br>are 6"/7"/8" PU wheels with height<br>adjustable forks and the rear wheels<br>are 20"/22"/24"* 1-3/8"<br>polyurethane<br>(MA012 and MS019).<br>Aluminum frame with liquid coated<br>and folding backrest Flip-up and<br>detachable armrest PU pad<br>Detachable footrest Front casters PU<br>tires and quick release rear wheel<br>PU tires Nylon cushion | Similar<br>The structure<br>and materials<br>of main frame<br>of the proposed<br>device and<br>predicate device<br>are same, only<br>individual<br>materials are<br>different, such<br>as back upholstery<br>and seat<br>upholstery,etc.<br>The differences<br>do not raise<br>safety and<br>effectiveness<br>of the proposed<br>device. | | Material | Frame, crossbrace, crossbar, armrest,<br>brake: Aluminum, yellow/black<br>coating<br>Handgrip, side panel, handrim,<br>footplate: PVC<br>Seat and back upholstery: Cover is<br>Nylon fabrics, inside with flame | AST Model MA012 Rehab<br>Wheelchair: Aluminum frame<br>with liquid coated and folding<br>backrest Flip-up and detachable<br>armrest PU pad<br>Detachable footrest Front casters PU<br>tires and quick release rear wheel | Similar<br>The Main<br>Structural<br>materials and<br>wheels materials<br>are same.<br>The differences | | | resistant foam<br>Armrest pad: flame retardant sponge &PU | PU tires Nylon cushion | do not raise<br>safety and<br>effectiveness<br>of the proposed<br>device. | | Components | Main frame, back upholstery, seat<br>upholstery, handgrip, arm pad,<br>armrest, front wheel, rear wheel,<br>handrim, anti-tipper, crossbrace,<br>crossbar, side panel, Legrest strap,<br>footplate, Seat belt, brake | AST Model MA012 Rehab<br>Wheelchair: Main frame, handle<br>sleeve, back upholstery, seat<br>upholstery, armrest pad, armrest,<br>side<br>panel, front casters, rear wheel,<br>legrest, footplate, brake, front fork,<br>crossbrace. | Same<br>Although the<br>expressions are<br>different, the<br>main components<br>are same. | | Control Mode | Mechanical | Mechanical | SE | | Size(unfold) | 1100mm (L) *660mm (W) * 910mm (H) | 1173mm(L)*645mm(W)*892mm(H) | Similar<br>The two physical<br>dimensions are<br>different. The<br>difference does<br>not affect the<br>effectiveness<br>and safety | | Weight(Total) | 16kg(35.2lbs) | 38lbs | Similar<br>The proposed<br>device is<br>heavier than<br>the predicate<br>device. | | Weight<br>Capacity | 136Kg(300lbs) | Model MA012:<br>300lbs/136kg | Same | | Seat Width | 480mm | Model MA012:<br>16"(406mm)<br>18"(457mm)<br>20"(508mm) | Similar<br>Different seat<br>sizes do not<br>raise the safety<br>and effectiveness<br>of the device. | | Seat height | 540mm | Model MA012:<br>19.7"(500mm) | | | Seat depth | 420mm | Model MA012:<br>16"-20"(406mm-508mm) | | | Frame Type | foldable | foldable | SE | | Cross-brace<br>configuration | 18" | 14", 16", 18", 20" or 22" | SE | | Back Stype | Fixed | Model MS019:<br>Fixed | Same | | | | Adjustable | device is same<br>as predicate<br>device model<br>MS019. | | Anti-tippers | Optional | Optional | Same | | Wheel<br>construction | Quick release | Model MA012:<br>Quick release<br>Model MS019:<br>Fixed | Same<br>Wheel<br>construction of<br>proposed<br>device is same<br>as predicate<br>device model<br>MA012. | | Tires | Front: 200mm(8")<br>Rear:610mm(24") | Front: 6",7",8"<br>Rear: 20",22",24" | SE | | Armrest | Flip back armrest | Model MA012:<br>Height Adjustable<br>desk length armrest,<br>Flip back<br>Model MS019:<br>Fixed or adjustable<br>height; desk or full<br>length; removable | Similar<br>The height of<br>armrest of<br>proposed<br>device can not<br>be adjustable. | | Foot rest | Optional/swing away Optional/<br>swing away | Optional/swing away Optional/<br>swing away | SE | | Rear Axle<br>Position | Single | Multiple | Similar<br>The rear axle<br>of proposed<br>device has only<br>one size. | | Frame<br>Construction | Foldable frame | Foldable frame | SE | | Frame<br>Material | Aluminum | Model MA012:<br>Aluminum<br>Model MS019: Steel | SE<br>The frame<br>materialof<br>proposed<br>device is same<br>as predicate<br>device model<br>MA012. | | Safety Feature | Manual Wheel Lock | Manual Wheel Lock | SE | | Standard | ISO7176-1<br>ISO7176-3<br>ISO7176-5 | ISO7176-1<br>ISO7176-3<br>ISO7176-5 | SE | | ISO7176-7 | ISO7176-7 | | | | ISO7176-8 | ISO7176-8 | | | | ISO7176-11 | ISO7176-11 | | | | ISO7176-13 | ISO7176-13 | | | | ISO7176-15 | ISO7176-15 | | | | ISO7176-16 | ISO7176-16 | | | | ISO10993-1 | ISO10993-1 | | | | ISO10993-5 | ISO10993-5 | | | | ISO10993-10 | ISO10993-10 | | | #### Comparison of technological characteristics with the predicate device VI. {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ #### VII. Performance Data ### The following performance data were provided in support of the substantial equivalence determination. ### Non-Clinical Test Non-clinical tests were conducted to verify that the proposed device met all design specificationsas was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - A ISO 10993-1 :2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - > ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In VitroCytotoxicity - ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin > Sensitization - > 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, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space - > ISO 7176-7. First Edition 1998-05-15, Wheelchairs - Part 7: Measurement of seating and wheeldimensions - > ISO 7176-8:2014, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatiguestrengths - > ISO 7176-11:2012 Test dummies - > ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of test surfaces - > ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling - > ISO 7176-16: 2012 Resistance to ignition of postural support devices ### Substantial Equivalence discussion: Our device and the predicate device are almost identical in terms of all areas described in the above table (Table 1). There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device. The following table (Table 2&3) shows similarities and differences of the performance between our device and the predicate device. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for "Manual Wheelchair A011" met all relevant requirements in the test standards, our internal specifications, and are comparable to the predicate device. {9}------------------------------------------------ | Description | Proposed Device | Predicate device | |-------------------------------------------------------|------------------------|------------------------| | Static stability | Meets ISO 7176-1:2014 | Meets ISO 7176-1:2014 | | Effectiveness of brakes | Meets ISO 7176-3:2012 | Meets ISO 7176-3:2012 | | Dimensions, mass and maneuvering space | Meets ISO 7176-5:2008 | Meets ISO 7176-5:2008 | | Seating and wheel dimensions | Meets ISO 7176-7:1998 | Meets ISO 7176-7:1998 | | Static, impact, and fatigue strengths | Meets ISO 7176-8:2014 | Meets ISO 7176-8:2014 | | Information disclosure, documentation and<br>labeling | Meets ISO 7176-15:1996 | Meets ISO 7176-15:1996 | | Resistance to ignition | Meets ISO 7176-16:2012 | Meets ISO 7176-16:2012 | ### Table 2 Performance comparison ### Table 3 Biocompatibility Comparison | Item | Proposed device | Predicate device | Result | |---------------|-------------------------------------------------------------|--------------------------|--------| | Cytotoxicity | Under the conditions of the study, not cytotoxicity effect. | Comply with ISO 10993-5 | Same | | Irritation | Under the conditions of the study, not an irritant. | Comply with ISO 10993-10 | Same | | Sensitization | Under the conditions of the study, not a sensitizer. | Comply with ISO 10993-10 | Same | ### Difference analysis: The tests were performed following the general requirements outlined in ISO 7176-11:2012, ISO 7176-13:1989. A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Proposed Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses: Manual wheelchair is safe and effective, and its performances meet the requirements of the pre-defined acceptance criteria and intended use. A brief discussion of the clinical submitted, reference, or relied on in the premarket notification for a determination of substantialequivalence. According to the non-clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. ## Animal Study No clinical study is included in this submission. ## Clinical Study No clinical study is included in this submission. #### VIII. Conclusion Based on the comparison of the proposed device of A011 is determined to be Substantially Equivalent (SE) to the predicate device of AST Model MA012 and MS019 Rehab Wheelchair, in respect of safety and effectiveness.