Multifunctional wheelchair (YJ-059)
Device Facts
| Record ID | K261919 |
|---|---|
| Device Name | Multifunctional wheelchair (YJ-059) |
| Applicant | Zhenjiang Assure Medical Equipment Co., Ltd. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Sep 16, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
Indications for Use
The device is to provide mobility to persons limited to a sitting position.
Device Story
Manual wheelchair (YJ-059) for passive users; provides mobility to individuals limited to sitting position. Features seat tilting mechanism, reclining backrest, adjustable-angle foldable footrests, and calf support. Operated manually by occupant or caregiver; includes both occupant-operated and caregiver-operated brakes. Used in indoor/outdoor environments with level, accessible ground. Enables postural adjustments (tilting/reclining) without transfers to enhance user comfort. Quick-release wheels facilitate transport. Output is physical mobility and postural support for the patient.
Clinical Evidence
No clinical data. Bench testing only. Device performance verified via ISO 7176 series (stability, brakes, dimensions, strength, friction, labeling, set-up) and ISO 16840-10 (ignition resistance). Biocompatibility verified via ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation).
Technological Characteristics
Manual, four-wheeled, foldable cross-brace wheelchair. Materials evaluated for biocompatibility per ISO 10993-1. Performance standards: ISO 7176-1, -3, -5, -7, -8, -11, -13, -15, -22; ISO 16840-10. Mechanical operation; no energy source. Features adjustable seat/backrest angles, calf support, and dual-brake system (occupant/caregiver).
Indications for Use
Indicated for adults (22 years and older) limited to a sitting position who require mobility assistance. Intended for use by the occupant or a caregiver. Maximum weight capacity 300 lbs.
Regulatory Classification
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
- Manual Wheelchair (A011) (K201461)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 16, 2026
Zhenjiang Assure Medical Equipment Co., Ltd.
% Eva Li
Consultant
Shanghai Sungo Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai, 200122
China
Re: K261919
Trade/Device Name: Multifunctional wheelchair (YJ-059)
Regulation Number: 21 CFR 890.3850
Regulation Name: Mechanical Wheelchair
Regulatory Class: Class I, reserved
Product Code: IOR
Dated: August 18, 2026
Received: August 19, 2026
Dear 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 (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
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K261919 - Eva Li
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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" (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
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K261919 - Eva Li
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(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).
Sincerely,
Tushar Bansal -S
for Heather Dean, PhD
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
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| 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. | K261919 | ? |
| Please provide the device trade name(s). | | ? |
| Multifunctional wheelchair (YJ-059) | | |
| Please provide your Indications for Use below. | | ? |
| The device is to provide mobility to persons limited to a 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) | ? |
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510(K) Summary - K261919
# 1. Submitter
Zhenjiang Assure Medical Equipment Co.,Ltd.
Address: No.799, Chuqiao Road, Zhenjiang City, Jiangsu Province, China
Contact Person: Christine Dong
Tel: +86 13451917629
Email: christine@assuremedical.com.cn
Submission Correspondent
Contact: Eva Li
Phone: + 86 (215) 881-7802
Email: jia.li@sungoglobal.com
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave, Shanghai, 200122 CHN
Prepared Date: Feb 24,2026
# 2. Device
Name of Device: Multifunctional wheelchair
Common Name: Manual Wheelchair
Model: YJ-059
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
YJ-059 manual wheelchair is a wheelchair for passive users, featuring a seat tilting mechanism, a reclining backrest, and foldable footrests with adjustable angles. It is intended for users who require postural adjustments, such as seat and backrest reclining, to enhance comfort.
It is suitable for both indoor and outdoor use, provided that the ground is level and accessible. This wheelchair enables controlled tilting, which facilitates changes in the user's position without the need for transfers. The wheels of the device can be quick-released.
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510(K) Summary - K261919
# 5. Indication for use
The device is to provide mobility to persons limited to a sitting position.
6. Application: An adult user weight of no more than 300LBS, and the passenger capacity is only 1. The intended users are the wheelchair occupant and/or a caregiver.
7. The specification table is as below:
| Model | YJ-059 | | |
| --- | --- | --- | --- |
| Overall dimension(L*W*H)(mm) | (1190-1265)*670*(900-1170) | | |
| Folded dimension | width 1000mm,height 760mm | | |
| Seat width | 425mm | Seat plane angle | 56° |
| Seat depth | 440mm | Seat height from edge | 530-660mm |
| Backrest angle | 67° | Backrest height | 520mm |
| Backrest width | 370-420mm | Footrest-to-seat distance | 520-430mm |
| Footrest clearance | 10mm | Footrest length | 160mm |
| Total mass | 44.65kg | Mass of heaviest part | 31kg |
| Armrest-to-seat distance | 190-230mm | Footrest-leg-angle | 90° |
| Leg-to-seat-surface angle | 108° -180° | Front-armrest-to-backrest distance | 470mm |
| Armrest height | 190-230mm | Armrest length | 450mm |
| Armrest width | 80mm | Armrest angle | 3° |
| Distance between armrests | 410mm | Front location of armrest structure | 740-790mm |
| Hand rim diameter | 530mm | Castor wheel diameter | 20mm |
| Propelling wheel diameter | 600mm | Static stability downhill | 10.05° |
| Static stability uphill | 10.15° | Static stability sideways | 10.2° |
| Parking brake | | | |
| Max slope uphill | | 7.10° | |
| Max slope downhill | | 7.05° | |
# 7. Comparison of technological characteristics with the predicate device
| Device | Predicate Device | Subject Device | Results |
| --- | --- | --- | --- |
| 510K Number | K201461 | | — — |
| Manufacturer | Ningbo Shenyu Medical Equipment Co., Ltd. | Jiangsu Assure Medical Equipment Co., Ltd. | — — |
| Proprietary Name | Manual Wheelchair | Multifunctional wheelchair | — — |
| Model | A011 | YJ-059 | — — |
| Classification | I | I | same |
| Indications for use | The A011 Manual wheelchair is to | The device is to provide mobility | same |
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# 510(K) Summary - K261919
| | provide mobility to persons limited to a sitting position. | to persons limited to a sitting position. | |
| --- | --- | --- | --- |
| Design Characteristic | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to-Lock, Armrest, Backrest, Foot rest | Manual Operation, Four-Wheels, foldable,Cross-Brace, Armrest, Backrest, Foot rest, calf support | Similar*1 |
| Brake control | occupant-operated brake only | occupant-operated brake nursing people operated brake | Different*1 |
| Operation Environment | For indoor/outdoor use | For indoor/outdoor use | same |
| Control Mode | Mechanical | Mechanical | same |
| Size(unfold) | 1100 (L) *660 (W) * 910mm (H) | (1190-1265)(L)*670(W)*(900-1170)(H)mm | Different*2 |
| Stowage length/width/height | 810 (L) X 320 (W) X 930mm (H) | 1000 (L)* 670 (W)*760mm(H) | different*2 |
| Weight(Total) | 16kg(35.2lbs) | 44.65kg | different*2 |
| Weight Capacity | 136Kg(300lbs) | 300LBS | same |
| Seat Width | 480mm | 425mm | different*2 |
| Seat height | 540mm | 530-660mm | different*2 |
| Seat depth | 420mm | 440mm | different*2 |
| Back type | Fixed | Adjustable | Different*3 |
| Tires | Front: 200mm Rear:610mm | Front: 20mm Rear:600mm | different*2 |
| Armrest | Flip back armrest | adjustable | different*3 |
| Foot rest | Optional/ swing away Optional/ swing away | adjustable | different*3 |
| Rear Axle Position | Single | Single | Same |
| Frame Construction | Foldable frame Push inward from left and right sides to fold | Back rest flip | Different*3 |
| 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 ISO7176-16 | Comply with: ISO7176-1 ISO7176-3 ISO7176-5 ISO7176-7 ISO7176-8 ISO7176-11 ISO7176-13 ISO7176-15 ISO7176-16 | Same |
| Biocompatibility | Comply with: ISO10993-1 ISO10993-5 ISO10993-10 | Comply with: ISO10993-1 ISO10993-5 ISO10993-10 ISO10993-23 | Similar*2 |
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510(K) Summary - K261919
# **Disscussion:**
| Similar*1: | Compare the predicate device, the subject device don't have the pull-to-lock feature, this will not raise any new risk of safety or effectiveness. |
| --- | --- |
| Different*1: | Compare the predicate device, the subject device adds a brake method, this feature will not raise any new risk of safety or effectiveness. |
| Different*2: | Compare the predicate device, the subject device have different value on the unfold size, device weight, Seat Width, Seat height, Seat depth, Tires size and so on. However the subject has pass the ISO 7176 related standard, so the above different will not raise any new risk of safety or effectiveness. |
| Different*3: | Compare the predicate device, the subject device' armrest, footrest is adjustable, and the backrest can be flip. These difference will not raise any new risk of safety or effectiveness. |
| Similar*2 | The stimulation test in ISO 10993-23 replaces the stimulation test in ISO 10993-10:2010, it will not raise any new risk of safety or effectiveness. |
# **8. 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 7176-22:2014 Wheelchairs — Part 22: Set-up procedures
ISO 16840-10:2024 Wheelchair seating-Part 10: Resistance to ignition of postural support devices-Requirements and test method, heat source: heating cartridge
# **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 10993-23:2010)
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510(K) Summary - - K261919---
The testing supports the biocompatibility of the patient-contacting device materials that were shown to be non-cytotoxic, non-irritating, and non-sensitizing. The biocompatibility of the subject device is based on the use of low-biocompatibility risk materials and supporting information in accordance with Attachment G of FDA’s 2023 Biocompatibility Guidance.
# **9. Clinical Test Conclusion**
No clinical study is included in this submission.
# **10. Conclusion**
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the subject device is as safe, as effective, as well as the legally marketed predicate device cleared under K201461.
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