Manual Wheelchair (A006)

{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 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. June 16, 2023 Ningbo Shenyu Medical Equipment Co., Ltd. % Eva Li Consultant Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave. Shanghai, 200122 China Re: K231110 Trade/Device Name: Manual Wheelchair (A006) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: March 13, 2023 Received: April 19, 2023 Dear Ms. Eva Li: 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. 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 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. {1}------------------------------------------------ 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) 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-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorywebsite the DICE assistance/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 L. Dean -S Heather Dean, Ph.D. Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K231110 Device Name Manual Wheelchair (A006) Indications for Use (Describe) The A006 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 #### 1. Submitter K231110 Ningbo Shenyu Medical Equipment Co.,Ltd. Address: No.1318 West of Tanjialing Road, Yuyao, Zhejiang, China Contact Person: Ding Jianjun Tel: +86- 574-62517777 Email: sales@shenyumedical.com Submission Correspondent Eva Li Contact: + 86 (215) 881-7802 Phone: Email: eatereva@hotmail.com Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave, Shanghai, 200122 CHN Prepared Date: May 10th,2023 #### 2. Device Name of Device: Manual Wheelchair Common Name: Manual Wheelchair Model(s): A006 Regulatory Information Classification Name: Mechanical Wheelchair Regulatory Class: I Product code: IOR Regulation Number: 890.3850 Review Panel: Physical Medicine #### 3. Predicate device: K201461 Ningbo Shenyu Medical Equipment Co.,Ltd. Manual Wheelchair (A011) This predicate has not been subject to a design-related recall. #### 4. Device description The subject device is a mechanical wheelchair which is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bringing the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to maneuver the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the {4}------------------------------------------------ tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant. #### Main Components: Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, rear wheel, hand rim, crossbar, leg rest strap, footrest, seat belt, brake The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions. | Overall dimension | 1000(L)*690(W)*875(H) mm | | | |-----------------------------------------|--------------------------------------------------|----------------------------------------|----------------------------| | Folded dimension | 800(L)*325(W)*875(H) mm | | | | Seat width | 425 mm | Seat plane angle | 10.4 ° | | Seat depth | 425 mm | Seat height from floor | 445 mm | | Backrest angle | 21.1° | Backrest height | 470 mm | | Backrest width | 430 mm | Footrest-to-seat distance | 295 mm(min)<br>350 mm(max) | | Footrest clearance | 110 mm(min)<br>160 mm(max) | Footrest length | 145 mm | | Armrest-to-seat distance | 260 mm | Footrest-leg-angle | 98.0°(min)<br>100°(max) | | Leg-to-seat-surface angle | 109° | Front-armrest-to-backrest<br>distance | 260 mm | | Front-armrest-to-backrest<br>distance | 430 mm | Armrest length | 365 mm | | Armrest width | 55 mm | Armrest angle | 4.3° | | Distance between<br>armrests | 425 mm | Front location of armrest<br>structure | 440 mm | | Hand rim diameter | Φ530 mm | Material | Aluminum | | Horizontal location of axle | 6 mm | Vertical displacement of<br>wheel axle | 73 mm | | Weight of the device(net) 14.0 kg | Maximum weight bearing<br>capacity of the device | 100 kg | | | diameter of front wheels | Φ185 mm | diameter of rear wheels | Φ595 mm | | Backpack carrier or<br>permission | L: 280 mm<br>W: 248 mm | Static stability sideways | 15° | | Static stability uphill | 10° | Static stability downhill | 10° | | Minimum doorway entry depth | | 1250 mm | | | Minimum turning radius | | 900 mm | | | Minimum corridor width for side opening | | 1170 mm | | | Parking brake | | | | | Max slope uphill | | 12.9° | | | Max slope downhill | | 10.6° | | | Bake operating force | | 63.9 N | | The specification table is as below: {5}------------------------------------------------ #### Ningbo Shenyu Medical Equipment Co.,Ltd. Address: No.1318 West of Tanjialing Road,Yuyao,Zhejiang,China #### 5. Indication for use The A006 Manual Wheelchair is to provide mobility to persons limited to a sitting position. #### 6. Comparison of technological characteristics with the predicate device | Device | Predicate Device | Proposed Device | Results | |--------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|-------------| | 510K Number | K201461 | K231110 | | | Manufacturer | Ningbo Shenyu Medical Equipment<br>Co., Ltd. | Ningbo Shenyu Medical Equipment<br>Co., Ltd. | Same | | Proprietary Name | Manual Wheelchair | Manual Wheelchair | Same | | Model | A011 | A006 | | | Classification | I | I | Same | | Indications for use | The A011 Manual wheelchair is to<br>provide mobility to persons limited<br>to a sitting position. | The A006 Manual Wheelchairs is to<br>provide mobility to persons limited<br>to a sitting position. | Same | | Design<br>Characteristic | Manual Operation, Four-Wheels,<br>Foldable, Cross-Brace, Pull-to-Lock,<br>Armrest, Backrest, Foot rest | Manual Operation, Four-Wheels,<br>Foldable, Cross-Brace, Pull-to-Lock,<br>Armrest, Backrest, Foot rest, skirt<br>guard | Similar*1 | | Brake control | Occupant-operated brake only | 1. Occupant-operated brake<br>2. Attendant-operated brake | Similar*2 | | Operation<br>Environment | For indoor/outdoor us | For indoor/outdoor us | Same | | Control Mode | Mechanical | Mechanical | Same | | Size(unfold) | 1100 (L)*660 (W) * 910 mm (H) | 1000 (L)*690 (W)*875 (H) mm | Different*3 | | Stowage<br>length/width/height | 810 (L)*320 (W) * 930 mm (H) | 800 (L)*325 (W)*875 (H) mm | Different*3 | | Weight(Total) | 16 kg (35.2 lbs) | 14 kg (30.9 lbs) | Different*3 | | Weight Capacity | 136 kg(300 lbs) | 100 kg(220 lbs) | Different*3 | | Seat Width | 480 mm | 425 mm | Different*3 | | Seat height | 540 mm | 425 mm | Different*3 | | Seat depth | 420 mm | 445 mm | Different*3 | | Back type | Fixed | Fixed | Same | {6}------------------------------------------------ ## Ningbo Shenyu Medical Equipment Co.,Ltd. Address: No.1318 West of Tanjialing Road, Yuyao, Zhejiang, China | Anti-tippers | Optional | Without Anti-tippers | Different*4 | |--------------------|--------------------------------------------------|--------------------------------------------------|-------------| | Tires | Front: 200 mm (8") | Front: 185 mm (7") | Different*3 | | | Rear: 610 mm (24") | Rear: 595 mm (23") | | | Armrest | Flip back armrest | Fixed armrest | Different*5 | | Foot rest | Optional/swing away | Fixed/swing away | Different*5 | | Rear Axle Position | Single | Single | Same | | Frame | Foldable frame | Foldable frame | Same | | Construction | Push inward from left and right<br>sides to fold | Push inward from left and right<br>sides to fold | Same | | | Safety Feature | Manual Wheel Lock | | | Performance | Comply with: | Comply with: | Same | | | ISO7176-1 | ISO7176-1 | | | | ISO7176-3 | ISO7176-3 | | | | ISO7176-5 | ISO7176-5 | | | | ISO7176-7 | ISO7176-7 | | | | ISO7176-8 | ISO7176-8 | | | | ISO7176-11 | ISO7176-11 | | | | ISO7176-13 | ISO7176-13 | | | | ISO7176-15<br>ISO7176-16 | ISO7176-15<br>ISO7176-16 | | | Biocompatibility | Comply with: | Comply with: | Same | | | ISO10993-1<br>ISO10993-5 | ISO10993-1<br>ISO10993-5 | | | | ISO10993-10 | ISO10993-10 | | # Disscussion : | Similar*1: | Compare the predicate device, the subject device adds two skirt guard which<br>are installed to the sides of the seat frame under the arm rests to provide a<br>barrier between the occupants and the wheels. This feature can prevent<br>occupants clothes from getting caught in the wheels. This feature will not raise<br>any new risk of safety or effectiveness. | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Similar*2: | Compare the predicate device, the subject device adds attendant-operated brakes<br>which the attendant can squeeze upwards the brake hand grip to brake the device.<br>The subject device passed the test of <ISO 7176-3-2012 Part3: Determination of<br>effectiveness of brakes>, so it will not raise any new risk of safety or effectiveness. | | Different*3: | Compare the predicate device, the subject device has different values on the<br>unfold size, stowage size, device weight, capacity, seat width, seat height, seat<br>depth, tire size. However, the subject has passed the <ISO 7176-7-1998 Part7:<br>Measurement of seating and wheel dimensions> and <ISO 7176-5-2008 Part 5:<br>Determination of dimensions, mass and maneuvering space>, so the above<br>difference will not raise any new risk of safety or effectiveness. | | Different*4: | Compare the predicate device, the subject device does not equip Anti-tippers.<br>However the subject device pass the test < ISO 7176-1-2014 Wheelchairs- | {7}------------------------------------------------ #### Ningbo Shenyu Medical Equipment Co.,Ltd. Address: No.1318 West of Tanjialing Road, Yuyao, Zhejiang, China | | risk of safety or effectiveness. | |--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Different*5: | Compare the predicate device, the subject's armrest is fixed, the foot rest is fixed as well. However, the subject device passed the test of <ISO 7176-8-2014 Wheelchairs- Part 8: Requirements and test methods for static, impact and fatigue strengths>, so this difference will not raise any new risk of safety or effectiveness. | ### 7. Summary of Non-Clinic Performance Testing ### Performance Testing Non-clinical tests were conducted to verify that the subject 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: 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 overall dimensions, mass and maneuvering 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 devices ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures ## Biocompatibility Biocompatibility testing was conducted in accordance with the 2020 FDA guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process." Testing included: - Cytotoxicity (ISO 10993-5:2009) - · Sensitization (ISO 10993-10:2010) - · Irritation (ISO 10993-10:2010) The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing. #### 8. Clinical Test Conclusion No clinical study is included in this submission. #### 9. Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Manual Wheelchair is as safe, as effective, as well as the legally marketed predicate device cleared under K201461.