Manual Wheelchair (H008, PCK7)

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION August 6, 2026 Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Fang (Fawn) Zhang Director of Regulatory and Compliance Yunyang Industrial Park Danyang City #1 Baisheng Rd. Development Zone Danyang Jiangsu, / 212300 China Re: K261571 Trade/Device Name: Manual Wheelchair (H008, PCK7) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: May 11, 2026 Received: May 12, 2026 Dear Fang (Fawn) Zhang: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261571 - Fang (Fawn) Zhang Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K261571 - Fang (Fawn) Zhang Page 3 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, # Tushar Bansal -S Tushar Bansal, PhD Acting Assistant Director, Acute Injury 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261571 | ? | | Please provide the device trade name(s). | | ? | | Manual Wheelchair (H008, PCK7) | | | | Please provide your Indications for Use below. | | ? | | The Manual Wheelchair is to provide mobility to people limited to sitting position. | | | | Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} 510(k) Summary - K261571 # 510(k) Summary - K261571 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92. ## 1.0 Submitter's Information Submitter's Name: Jiangsu Yuyue Medical Equipment & Supply Co., LTD. Address: Yunyang Industrial Park Danyang City, Jiangsu 212300 China Contact Person: Fang (Fawn) Zhang Contact Title: JD. PharmD, RAC Director of Regulatory and Compliance Contact E-mail Address: Fawn.zhang@yuyue.com.cn Zip code: 212300 Telephone: (206) 639-1311 Date of Preparation: Jan.7th, 2025 ## 2.0 Subject Device Information Common Name: Manual Wheelchair Proprietary Name: Manual Wheelchair Model:H008, PCK7 Regulation Name: Wheelchair, Mechanical Product Code: IOR Regulation Number:890.3850 Regulation Class:1 ## 3.0 Predicate Device Information Manufacturer: Zhenjiang Assure Medical Equipment Co., Ltd. Trade/Device: Reclining wheelchair (YJ-011S 16"D, YJ-011S 16"DF, YJ-011S 18"D, YJ-011S 18"DF, YJ-011S 20"D, YJ-011S 20"DF) 510(k) number: K232198 ## 4.0 Indication for Use Statement The Manual Wheelchair is to provide mobility to people limited to sitting position. ## 5.0 Subject Device Description The subject device, mechanical wheelchair, is a manually operated device with wheels that is intended for medical purposes to provide mobility to people limited to 1 of page 6 {5} 510(k) Summary - K261571 sitting position. The 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 handgrips behind the seat for someone else to do the pushing. The components include a frame, a backrest, a seat cushion, two handgrips, two removeable armrests, two armrest pads, two side panels, two rear wheels, two hand rims, two wheel locks, two front wheels with forks, and footrests with footplates. The subject device has two models: Model H008 and Model PCK7 - H008: two 8 inch front wheels and two 24 inch rear wheels, a steel frame and a PVC upholstery that is flame resistant. Armrest is removeable. It has elevating legrest. Main materials: Steel (frame, armrest, wheel lock), PVC leather (armrest pad, backrest, seat cushion). Its maximum loading can not be over 150kgs (around 330lbs). - PCK7: two 8 inch front wheels and two 24 inch rear wheels, a steel frame and a PVC upholstery that is flame resistant. Armrest is removeable. It has elevating legrest. Main materials: Steel (frame, armrest, wheel lock), PVC leather (armrest pad, backrest, seat cushion). Its maximum loading can not be over 225kgs(around 496lbs). ### 6.0 Technological Characteristic Comparison Table Table 1 - General Comparison | Device | Subject Device | Predicate Device | Results | | --- | --- | --- | --- | | 510(k) Number | K261571 | K232198 | -- | | Manufacturer | Jiangsu Yuyue Medical Equipment & Supply CO., LTD. | Zhenjiang Assure Medical Equipment Co., Ltd. | -- | | Proprietary Name | Manual wheelchair | Reclining wheelchair | Same | | Model | H008, PCK7 | YJ-011S 16"D, YJ-011S 16"DF, YJ-011S 18"D, YJ-011S 18"DF, YJ-011S 20"D, YJ-011S 20"DF | | | Classification | I | I | Same | | Indications for use | Manual Wheelchair is to provide mobility to people limited to a sitting position. | The YJ-011S reclining wheelchair is to provide mobility to persons limited to a sitting position. | Same | 2 of page 6 {6} 510(k) Summary - K261571 | Design Characteristic | Manual Operation, Four-Wheels, Foldable, X-Brace, Push-to-Lock, Armrest, Backrest, Footrest, skirt guard | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to-Lock, Armrest, Backrest, Foot rest, skirt guard | Similar | | --- | --- | --- | --- | | Brake control | Occupant-operated brake only | Occupant-operated brake only | Same | | Operation Environment | For indoor/outdoor use | For indoor/outdoor use | Same | | Control Mode | Mechanical | Mechanical | Same | | Size(unfold) (mm) | H008: 1270×685×1280mm PCK7: 1320×770×1320mm (L*W*H) | 1340 (L)* 1258 (H) *16" 625mm(W) *18" 675mm(W) *20" 725mm(W) | NOTE1 | | Stowage length/width/height (mm) | H008:1270×290×1280(L*W*H) PCK7:1320×400×1320(L*W*H) | 1340 (L)* 1258 (H)*323(W) | NOTE2 | | Weight (Total) | H008:24kg PCK7:30kg | 25.5kg | NOTE3 | | Weight Capacity | H008:150kg (around 330lbs) PCK7:225kg (around 496lbs) | 350lbs | NOTE4 | | Seat Width | H008:500mm PCK7:610mm | 410-510mm | NOTE5 | | Seat height | H008:500mm PCK7:480mm | 525mm | NOTE6 | | Seat depth | H008:385mm PCK7:510mm | 460mm | NOTE7 | | Back type | Adjustable | Adjustable | Same | | Tires | Front: 193mm Rear:610mm | Front: 195mm Rear:613mm | NOTE8 | | Armrest | Removeable | fixed | NOTE9 | | Footrest | elevating legrest | Optional/ swing away Optional/ swing away | NOTE10 | | Rear Axle Position | Single | Single | Same | | Frame Construction | Foldable frame Push inward from left and right | Foldable frame Push inward from left and | Same | 3 of page 6 {7} 510(k) Summary - K261571 | | sides to fold | right sides to fold | | | --- | --- | --- | --- | | Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same | | Performance | Comply with: ISO7176-1 ISO7176-3 ISO7176-5 ISO7176-7 ISO7176-8 ISO7176-11 ISO7176-13 ISO7176-15 ISO7176-22 ISO16840-10 | Comply with: ISO7176-1 ISO7176-3 ISO7176-5 ISO7176-7 ISO7176-8 ISO7176-11 ISO7176-13 ISO7176-15 ISO7176-16 | Same | | Biocompatibility | Comply with: ISO10993-5 ISO10993-10 ISO10993-23 | Comply with: ISO10993-5 ISO10993-10 ISO10993-23 | Same | #### Summary of Substantial Equivalence Discussion: NOTE1、2、3、5、6、7、8: Compared to the predicate device, the subject device has different value on the unfold size, stowage size, device weight, seat height, seat depth, and tire size. However, the subject devices have passed the ISO 7176-7-1998 and ISO 7176-5-2008, so the above different will not raise any new risk of safety or effectiveness. NOTE 4: The Maximum loading is different with the predicate device. The subject manual wheelchair has already been tested for performance according to ISO 7176-1/-3/-8/-11/-13/-15 and complies with the standards. Therefore, the subject manual wheelchair is as safe, effective and performs as well as the legally marketed predicate device. NOTE9: Compare the predicate device, the subject's armrest is Removeable. However, the subject device passed the test of ISO 7176-1/-8, so this difference will not raise any new risk of safety or effectiveness. NOTE10: Compare the predicate device, the subject's foot rest is elevating legrest. However, the subject device passed the test of ISO 7176-1/-8, so this difference will not raise any new risk of safety or effectiveness. Similar: Compare the predicate device, the subject's Wheel Lock is a push lock. However, the subject device passed the test of ISO 7176-3, so this difference will not raise any new risk of safety or effectiveness. Despite of the above slight differences, the two devices all completed the 4 of page 6 {8} 510(k) Summary - K261571 performance tests in accordance with ISO 7176 series standards. There are no safety and effectiveness aspects concerned. In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The slight differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. ### 7.0 Summary of Non-Clinical 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 subject 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 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 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements and test method ISO 7176-22:2014 Wheelchairs - Part 22: Set-up procedures ### Biocompatibility of User-contacting Parts User-contacting material are carried out biocompatibility assessment in accordance with ISO 10993-1: 2018, including: Cytotoxicity per ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity Skin Sensitization per ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization. Irritation per ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 23: Tests for Irritation. ### 8.0 Summary of Clinical Testing No clinical study implemented for the wheelchair. 5 of page 6 {9} 510(k) Summary - K261571 ## 9.0 Conclusion The conclusions drawn from the comparison and analysis above demonstrate that the subject device is as safe and effective as the legally marketed predicated device in K232198 and raises no new questions of safety or effectiveness. The differences between both devices are insignificant in terms of safety and effectiveness. 6 of page 6