← Product Code [IOR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR) · K260121 # Manual Wheelchair (7101L, 7102LHD) (K260121) _Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · IOR · Apr 28, 2026 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K260121 ## Device Facts - **Applicant:** Foshan Nanhai Hongchen Medical Equipment Co., Ltd. - **Product Code:** [IOR](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR.md) - **Decision Date:** Apr 28, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.3850 - **Device Class:** Class 1 - **Review Panel:** Physical Medicine ## Indications for Use The manual wheelchair is a manually operated wheelchair intended to be used as a means of mobility for individuals restricted to a sitting position. ## Device Story Manual wheelchair for adult mobility; provides sitting support for indoor/outdoor use. Device components include frame, armrests, push handles, foot brackets/pedals, brakes, wheels, seat/back upholstery, and optional anti-tippers. Operated manually by user or caregiver. Provides mechanical mobility assistance; enhances patient independence. No electronic or software components. ## Clinical Evidence No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing per ISO 7176 standards, including static stability, brake effectiveness, dimensions, and structural strength (static, impact, fatigue). ## Technological Characteristics Mechanical, manually operated wheelchair. Materials: composite-based. Dimensions: 7101L (43cm seat width, 11.2kg) and 7102LHD (54cm seat width, 12.3kg). Features: push-to-lock brakes, optional anti-tippers. Standards: ISO 7176-1, -3, -7, -8, -11, -13, -15, -22. ## Regulatory Identification A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. ## Predicate Devices - Bowhead ERA Wheelchairs ([K243111](/device/K243111.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION April 28, 2026 Foshan Nanhai Hongchen Medical Equipment Co., Ltd. Jinghan Tang General Manager Factory F, # 2, Nansha Rd., Nansha Community Danzao Town, Nanhai District, Foshan City Foshan, Guangdong 528000 China Re: K260121 Trade/Device Name: Manual Wheelchair (7101L, 7102LHD) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: March 30, 2026 Received: March 30, 2026 Dear Jinghan Tang: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260121 - Jinghan Tang Page 2 (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-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). {2} K260121 - Jinghan Tang Page 3 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} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K260121 Device Name Manual Wheelchair (7101L, 7102LHD) Indications for Use (Describe) The manual wheelchair is a manually operated wheelchair intended to be used as a means of mobility for individuals 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 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." {4} 510(k) Summary - K260121 1. Submission sponsor Name: Foshan Nanhai Hongchen Medical Equipment Co., Ltd. Address: Factory F, No. 2, Nansha Road, Nansha Community, Danzao Town, Nanhai District, Foshan City, Guangdong Province, P.R. China Contact person: Lei Wang Title: Sales Manager Tel: +86-0757-86776282 Email: Ray18675191911@163.com 2. Submission correspondent Contact person: Jinghan Tang Title: General Manager Tel: +8613537831351 Email: Jinghan_tang@126.com 3. Device Name of Device: Manual Wheelchair Model(s): 7101L, 7102LHD Classification Name: Wheelchair, Mechanical Regulatory Class: I Product Code: IOR Regulation Number: 21 CFR 890.3850 4. Predicate device(s) | Manufacturer | Predicate Device | 510(k) Number | | --- | --- | --- | | Bowhead Design Corp. | Bowhead ERA Wheelchairs | K243111 | {5} 5. Device description The Manual Wheelchairs are composite based mechanical, manually operated, wheelchairs intended to be used as a means of mobility for adults restricted to a sitting position. The Manual Wheelchairs include 2 mechanical wheelchair models with each model containing slightly different design features. This product consists of a frame, armrest, push handle, foot bracket, foot pedal, brake, front and rear wheels, seat upholstery, back upholstery, and Anti-tippers. 6. Indications for Use The manual wheelchair is a manually operated wheelchair intended to be used as a means of mobility for individuals restricted to a sitting position. 7. Comparison of Technological Characteristics with the Predicate Device(s) The Manual Wheelchair has the same intended use, mode of action and operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, The Manual Wheelchair may be found substantially equivalent to its predicate devices. The Manual Wheelchair is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance: K243111 (Predicate Device), " Bowhead ERA Wheelchairs ", manufactured by " Bowhead Design Corp." | Comparison Elements | Subject Device | Predicate Device (K243111) | Remark | | --- | --- | --- | --- | | Device name | Manual Wheelchair | Bowhead ERA Wheelchairs | -- | | Indications for use | The manual wheelchair is a manually operated wheelchair intended to be used as a means of mobility for individuals restricted to a sitting position. | The Bowhead ERA wheelchairs are manually operated wheelchairs intended to be used as a means of mobility for individuals restricted to a sitting position. | SE | {6} | Comparison Elements | Subject Device | Predicate Device (K243111) | Remark | | --- | --- | --- | --- | | | | position. | | | Intended User | Adults | Adults | SE | | Rx/OTC | OTC | OTC | SE | | Operation Environment | indoor and outdoor use | indoor and outdoor use | SE | | Control Mode | Self/user propelled, manual mechanical wheelchair | Self/user propelled, manual mechanical wheelchair | SE | | Folding Method | Rigid | Rigid | SE | | Weight of Devices | 7101L:11.2kg with wheels7102LHD:12.3kg with wheels | 2.5-6 kg w/out wheels & dependent on configuration with or without removable seat. | SENote 1 | | Weight Capacity | 7101L:250lbs/113.4 kg7102LHD: 350 lbs/158.8 kg | 110 kg (~242.5 lbs) | SENote 2 | | Seat Width | 7101L:43cm7102LHD: 54cm | Adjustable:Small: 12” – 15”Medium: 14.5” – 17”Large: 17” – 19.5” | SENote 3 | | Seat Height | 7101L:45cm7102LHD: 45cm | Adjustable:16” – 21’ | SENote 3 | | Seat Depth | 7101L:45cm7102LHD: 56cm | 14”16”18” | SENote 3 | | Back Height | 7101L:42cm7102LHD: 42cm | 8-25in (dependent backrest selected) | SENote 3 | | Push Handle | Yes, optional | Yes, optional | SE | | Safety feature (manual wheel lock) | Yes, push to lock style. | Yes, push to lock style. | SE | {7} | Comparison Elements | Subject Device | Predicate Device (K243111) | Remark | | --- | --- | --- | --- | | Brakes | One hand operation | One hand operation | SE | | Anti-Tip | Yes - optional | Yes - optional | SE | Comparison in Detail(s): Note 1: Weight of Devices Minor difference on Weight of Devices will not cause new safety and effectiveness concerns raised as the subject device has been evaluated according to standard ISO 7176 series. The Weight of Devices differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use. Note 2: Weight Capacity The Weight Capacity of the subject device is a little higher than that of predicate device as the subject device has been evaluated according to standard ISO 7176 series. The Weight Capacity differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use. Note 3: Seat Width,Seat Height,Seat Depth,Back Height The Seat Width,Seat Height,Seat Depth,Back Height of the subject device is similar with that of the predicate device. The Seat Width,Seat Height,Seat Depth,Back Height differences between the subject and predicate devices does not raise new concerns of safety and effectiveness for the clinical use. 8. Test Summary of Non-clinical Testing The Manual Wheelchair has been evaluated the safety and performance by lab bench testing according to the following standards. 1) Performance test The test results meet the specification of the product and the relevant standards are listed below. - ISO 7176-1: 2014 Wheelchairs - Part 1: Determination of static stability - ISO 7176-3: 2012 Wheelchairs - Part 3: Determination of effectiveness of brakes - ISO 7176-7: 1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions {8} > 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 - Part15: Requirements for information disclosure, documentation and labeling > ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures ## 9. Summary of Clinical Test No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the Manual Wheelchair to its predicate device. ## 10. Conclusions In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the Manual Wheelchair is to be concluded substantial equivalent to its predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K260121](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K260121) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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