Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
Device Facts
| Record ID | K260141 |
|---|---|
| Device Name | Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C) |
| Applicant | Zhenjiang Assure Medical Equipment Co., Ltd. |
| Product Code | IOR · Physical Medicine |
| Decision Date | Sep 15, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
Indications for Use
The Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C) is to provide mobility to persons limited to a sitting position.
Device Story
Manually operated mechanical wheelchair; provides mobility to users limited to sitting position. Features main frame, seat, adjustable footplates, four wheels, and occupant-operated brakes. User maneuvers via hand rims on rear wheels or assistant pushes via rear handles. Foldable for transport. Used in indoor/outdoor environments on dry, level surfaces. Output is physical mobility for the patient; assists in daily navigation and independence. Benefits include improved mobility for bariatric patients.
Clinical Evidence
No clinical data. Bench testing only. Compliance with ISO 7176-1, -3, -5, -7, -8, -11, -13, -15, -22, and ISO 16840-10 verified structural integrity, stability, and brake effectiveness.
Technological Characteristics
Mechanical, manually operated wheelchair. Materials: Steel frame, Oxford fabric upholstery, Aluminum/Plastic footplates, PVC/PU tires, Polypropylene handrims. Foldable frame design. Standards: ISO 7176 series (stability, brakes, dimensions, strength, testing), ISO 10993-1/5/10 (biocompatibility), ISO 16840-10 (ignition resistance).
Indications for Use
Indicated for persons limited to a sitting position requiring mobility assistance. No specific age or gender restrictions provided.
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
- Bariatric Heavy Duty Wheelchair (K232199)
Reference Devices
Submission Summary (Full Text)
{0}
**U.S. FOOD & DRUG**
ADMINISTRATION
September 15, 2026
Zhenjiang Assure Medical Equipment Co., Ltd.
% Eric Shi
Deputy R&D Manager
Shanghai Jiushun Enterprise Management Technology Service Co
15 Floor, 25 Floor, Bao An Tower #800, Dongfang Rd.
Shanghai, 200122
China
Re: K260141
Trade/Device Name: Bariatric Heavy Duty Wheelchair (YJ-010V,YJ-010C)
Regulation Number: 21 CFR 890.3850
Regulation Name: Mechanical Wheelchair
Regulatory Class: Class I, reserved
Product Code: IOR
Dated: January 8, 2026
Received: January 20, 2026
Dear Eric Shi:
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}
K260141 - Eric Shi
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}
K260141 - Eric Shi
Page 3
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
{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.*
510(k) Number (*if known*)
K260141
Device Name
Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
Indications for Use (*Describe*)
The Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C) 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)
☑ 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."*
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
{4}
Sponsor: Zhenjiang Assure Medical Equipment Co.,Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
# 510(k) Summary
# K260141
# 1. Applicant Information
Company Name :Zhenjiang Assure Medical device
Co.,Ltd.
Establishment Registration Number:3007309323
Address:No.297,Chuqiao Road, Zhenjiang City, Jiangsu
Province, China. Phone:+86-13852941204
Contact Person (including title):Mei Ying (Deputy R&D Manager)
E-mail:shelly@assuremedical.com.cn
# 2. Primary Correspondent/Consultant Information
Company Name:Shanghai Jiushun Enterprise Management Technology Service Co.,Ltd.
Address:15 floor,25 floor,Bao An Tower,No.800,Dongfang Road,Shanghai,China.
Zip code:200122
Contact Person (including title):Eric Shi (Deputy R&D Manager) Phone:+86-18621771627
E-mail:eric-shi@isosh.com
Prepared Date: September 8,2026
# 3. Subject Device Information
Type of 510(k) submission: Special
Trade/Device Name: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
Regulation Name: Mechanical Wheelchair
Product Code: IOR Regulation Number:890.3850
Regulation Class:1
# 4. Predicate Device Information Sponsor:
Zhenjiang Assure Medical device Co.,Ltd.
Trade/Device Name: Bariatric Heavy Duty
Wheelchair
Model:YJ-010B 20"DS;YJ-010B 20"DE; YJ-010B 20"DFS;YJ-010B 20"DFE;YJ-010B 20"ADS;
YJ-010B 20"ADE;YJ-010B 20"ADFS;YJ-010B 20"ADFE;YJ-010B 22"DS;YJ-010B 22"DE;YJ-010B
22"DFS;YJ-010B 22"DFE;YJ-010B 22"ADS;YJ-010B 22"ADE;YJ-010B 22"ADFS;YJ-010B
22"ADFE;YJ-010B 24"DS;YJ-010B 24"DE;YJ-010B 24"DFS;YJ-010B 24"DFE;YJ-010B 24"ADS; YJ-010B
24"ADE;YJ-010B 22"ADFS; YJ-010B 24"ADFE
Regulation Name: Mechanical Wheelchair
Product Code: IOR
Regulation Number:890.3850
{5}
Sponsor: Zhenjiang Assure Medical Equipment Co.,Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
Regulation Class:1
510(k) number:K232199
## 5. General Description
The YJ-010V and YJ-010C are mechanical wheelchairs 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 footplates 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 tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.
### 5.1 Model(s)
YJ-010V,YJ-010C
### 5.2 Intended Use/Indications For Use
The Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C) is to provide mobility to persons limited to a sitting position.
### 5.3 Product Composition
Main frame, back upholstery, seat upholstery, handgrip, armrest, front wheel, rear wheel, hand rim, crossbar, leg rest strap, footplate, brake, leg rest.
The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
### 5.4 Human body Contacting Materials
#### 5.4.1 YJ-010C Model
| Patient Contacting Component | Material Name |
| --- | --- |
| Frame | Steel |
| Seat +Back upholstery | Oxford fabric |
| Front Fork | Steel |
| Footplate | Plastic/Aluminum |
| Tire | PVC |
#### 5.4.2 YJ-010V Model
{6}
Sponsor: Zhenjiang Assure Medical Equipment Co.,Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
| Patient Contacting Component | Material Name |
| --- | --- |
| Frame | Steel |
| Seat +Back upholstery | Oxford fabric |
| Handrim | Polypropylene (PP) |
| Front Fork | Aluminum |
| Footplate | Aluminum |
| Tire | PU |
5.5 Specification
| | YJ-010C | YJ-010V |
| --- | --- | --- |
| Overall length*width*height | 1090mm*700mm*910mm | 1310mm*950mm*900mm |
| Stowage length*width*height | 830mm*340mm*910mm | 890mm*340mm*940mm |
| Weight (Total) | 22kg | 32.97kg |
| Weight Capacity | 450LBS | 600LBS |
| Footplate clearance | 45mm | 50mm |
| Static stability uphill | 10.10° | 10.10° |
| Static stability downhill | 10.10° | 10.20° |
| Static stability sideways | 10.20° | 10.20° |
| Seat depth | 457mm | 500mm |
| Seat width | 20" 509mm | 26" 660mm |
| | 22" 559mm | 28" 710mm |
| | 24" 610mm | 30" 760mm |
| Backrest width | 20" 497mm | 26" 648mm |
| | 22" 547mm | 28" 698mm |
| | 24" 597mm | 30" 748mm |
| Backrest angle | 26.7° | 7° |
| Footplate-to-seat distance | 500mm | 415mm-500mm |
| Footplate length | 155mm | 220mm |
| Footrest-to-leg angle | 41° | 84.65° |
| Front-armrest-to-backrest Distance | 460mm | 430mm |
| Armrest length | 260mm | 260mm |
| Diameter of front wheels | Φ8X1.25"PVC | 8X2"PU |
| Diameter of rear wheels | 12 1/2 " PU | 24" PU |
| Uphill holding angle | 7.10° | 7.25° |
| Downhill holding angle | 7.10° | 7.20° |
{7}
Sponsor: Zhenjiang Assure Medical Equipment Co.,Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
### 6. Summary of Comparison and Technological Characteristics
Table 1-General Comparison
| Elements of Comparison | Predicate Device | Subject Device | Comment |
| --- | --- | --- | --- |
| K number | K232199 | N/A | N/A |
| Manufacturer | Zhenjiang Assure Medical device Co.,Ltd | Zhenjiang Assure Medical device Co.,Ltd | Same |
| Proprietary Name | Bariatric Heavy Duty Wheelchair | Bariatric Heavy Duty Wheelchair | Same |
| Classification | 1 | 1 | Same |
| Regulation Name | Mechanical Wheelchair | Mechanical Wheelchair | Same |
| Regulation Number | 890.3850 | 890.3850 | Same |
| Product Code | IOR | IOR | Same |
| Indications For Use | The YJ-010B Manual Wheelchair is to provide mobility to persons limited to a sitting Position | The YJ-010V,YJ-010C Manual Wheelchair is to provide mobility to persons limited to a sitting position | Same |
Table 2 Performance And Safety Comparison
| Elements of Comparison | Predicate Device | Subject Device | | Comment |
| --- | --- | --- | --- | --- |
| Model | YJ-010 | YJ-010C | YJ-010V | N/A |
| 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 |
{8}
**Sponsor:** Zhenjiang Assure Medical Equipment Co.,Ltd.
**Subject Device:** Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
| Size(unfold) | -E:1275mm(L)*1258mm(H)* 20"width 730mm/22"width 780mm/24"width 830mm -S:1175 mm(L)*1258mm(H) 20"width 730mm/22"width 780mm/24"width 830mm | m*700mm*91 0mm | m*950mm*9 00mm | Note 1 |
| --- | --- | --- | --- | --- |
| Stowage length/width/height | -E:1275mm(L)*1258mm(H)* 20"width 730mm/22"width 780mm/24"width 830mm | m*340mm*910 mm | m*340mm*94 0mm | Note 1 |
| | -S:1175 mm(L)*1258mm(H) 20"width 730mm/22"width 780mm/24"width 830mm | | | |
| Weight (Total) | 27.3-27.7Kg | 22kg | 32.97kg | Note 1 |
| Weight Capacity | 500LBS | 450LBS | 600LBS | Note 1 |
| Seat width | 509-610mm | 509-610mm | 660-760mm | Note 1 |
| Seat depth | 485mm | 457mm | 500mm | Note 1 |
| Backrest width | 497mm-497mm | 497mm-497mm | 648mm-748mm | Note 1 |
| Back type | Fixed | Fixed | | Same |
| Front wheel | Φ8X2"PU | Φ8X1.25"PVC | Φ8X2"PU | Note 1 |
| Rear wheels | 24" PU | 12 1/2 " PU | 24" PU | Note 1 |
| Armrest | Armrest height adjustable (- A)/fixed | Armrest height adjustable (- A)/fixed | | Same |
| Foot rest | with elevating leg rest /with swing-away leg rest | with elevating leg rest /with swing-away leg rest | | Same |
| Rear Axle Position | Single | Single | | Same |
| Frame Construction | Foldable frame Push inward from left and right sides to fold | Foldable frame Push inward from left and right sides to fold | | Same |
| Safety Feature | Manual Wheel Lock | Manual Wheel Lock | | Same |
{9}
Sponsor: Zhenjiang Assure Medical Equipment Co.,Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
| Frame material | Steel | Steel | | Same |
| --- | --- | --- | --- | --- |
| Seat +Back upholstery | PVC | Oxford fabric | | Note 2 |
| Handrim | Plastic/Steel | N/A | Polypropylene (PP) | Note 3 |
| Front Fork | Steel | Steel | Aluminum | Note 2 |
| Footplate | Plastic/Aluminum | Plastic | Aluminum | Same |
| Performance | Comply with:ISO 7176-1 ISO 7176-3 | Comply with:ISO 7176-1 ISO 7176-3 | | Same |
{10}
Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
| | ISO 7176-5 | ISO 7176-5 | |
| --- | --- | --- | --- |
| | ISO 7176-7 | ISO 7176-7 | |
| | ISO 7176-8 | ISO 7176-8 | |
| | ISO 7176-11 | ISO 7176-11 | |
| | ISO 7176-13 | ISO 7176-13 | |
| | ISO 7176-15 | ISO 7176-15 | |
| | ISO 7176-22 | ISO 7176-22 | |
| | | ISO 16840-10 | |
| Biocompatibility | Comply with: | Comply with: | Same |
| | ISO 10993-1 | ISO 10993-1 | |
| | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | |
#### Note 1
Compared to the predicate device, the subject device has different value on the unfold size, stowage size, device weight, capacity, seat width, Backrest width and tire size. However, the subject has passed the ISO 7176-7:1998 Part 7:Measurement of seating and wheel dimensions and ISO 7176-5:2008 Part 5:Determination of dimensions, mass and maneuvering space, so the above different will not raise any new risk of safety or effectiveness. All seat width configurations for both models (YJ-010C:20",22",24" and YJ-010V:26",28",30") were tested and passed the performance requirements. The YJ-010V model was tested in its worst-case backrest angle configuration (7°) and passed all static stability, brake effectiveness, and structural integrity tests.
#### Note 2
Compared to the predicate device, the subject device has different materials for the Seat/Back upholstery and Front Fork.
For the Seat/Back upholstery replacement (Oxford fabric vs. PVC) in the subject device: Oxford fabric (material: nylon) has been previously incorporated into mechanical wheelchairs approved under the same regulation (21 CFR 890.3850) and product code IOR, with similar intended use and technology (e.g., K252370). Additionally, the Oxford fabric has been tested for resistance to ignition in accordance with ISO 16840-10:2021+A1:2024 and passed the requirements. Since FDA has previously cleared devices under the same regulation and product code with comparable intended use, technology, and materials without identifying safety or effectiveness concerns, this difference does not impact safety and effectiveness of the subject device.
For the Front fork material change (Aluminum vs. Steel) in the YJ-010V model: The aluminum material used for the front fork has been previously cleared under 21 CFR 890.3850 and product code IOR (e.g., K112948). Since FDA has previously cleared devices under the same regulation and product code with comparable intended use, technology, and materials without identifying safety or effectiveness concerns, this difference does not impact safety and effectiveness of the subject device.
#### Note 3
The handrim material of the subject device (YJ-010V) is polypropylene (PP). Polypropylene (PP) is listed in Section B of Attachment G of FDA's guidance on the "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and it has a documented history of safe use in legally marketed medical devices in contact with intact skin (e.g., through Medical Device Reporting (MDR) analysis, literature search). This does not impact safety and effectiveness.
{11}
Sponsor: Zhenjiang Assure Medical Equipment Co.,Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
## 7. Summary of Non-Clinic Performance Testing
### 7.1 Bench Performance
Non-clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device.
Tested Configurations:
YJ-010C: All three seat width configurations (20",22",24") were tested. The 22" configuration was selected as the representative model for the test report, with verification that all configurations share the same structural design and materials.
YJ-010V: All three seat width configurations (26",28",30") were tested. The 26" configuration was selected as the representative model for the test report, with verification that all configurations share the same structural design and materials. The YJ-010V was tested in its worst-case backrest angle configuration (7°) for static stability, brake effectiveness, and structural integrity tests.
The test results demonstrated that the proposed device complies with the following standards:
16-195 ISO 7176-1 Third edition 2014-10-01
Wheelchairs-Part 1: Determination of static stability
16-192 ISO 7176-3 Third edition 2012-12-15
Wheelchairs-Part 3: Determination of effectiveness of brakes
16-163 ISO 7176-5 Second edition 2008-06-01
Wheelchairs-Part 5: Determination of overall dimensions, mass and manoeuvring space 16-196 7176-7 First Edition 1998-05-15
Wheelchairs-Part 7: Measurement of seating and wheel dimensions
16-197 7176-8 Second edition 2014-12-15
Wheelchairs-Part 8: Requirements and test methods for static, impact and fatigue strengths 16-190 ISO 7176-11 Second edition 2012-12-01
Wheelchairs-Part 11: Test dummies
16-25 ISO 7176-13 First edition 1989-08-01
Wheelchairs-Part 13: Determination of coefficient of friction of test surfaces
16-27 7176-15 First edition 1996-11-15
Wheelchairs-Part 15: Requirements for information disclosure, documentation and labeling 16-198 ISO 7176-22 Second edition 2014-09-01
Wheelchairs-Part 22: Set-up procedures
16-233 ISO 16840-10 Second edition 2021-06 Corrected version 2022-01
Resistance to Ignition of Postural Support Devices
### 7.2 Biocompatibility
No new biocompatibility testing was conducted. The subject device is submitted via the FDA Special 510(k) pathway, which aims to expedite review when existing cleared test data can support substantial equivalence without additional testing. All material changes in the subject device (Oxford fabric for seat/back upholstery, polypropylene (PP) for the handrim, and aluminum for front fork) have either been previously used in FDA-cleared mechanical wheelchairs under the same regulation and product code, with identical intended use and intact skin contact classification (e.g., K252370, K112948), or it is listed (i.e. PP) in section B of Attachment G of FDA's guidance on the "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". No new
{12}
Sponsor: Zhenjiang Assure Medical Equipment Co.,Ltd.
Subject Device: Bariatric Heavy Duty Wheelchair(YJ-010V,YJ-010C)
biocompatibility risks are introduced by these material changes, as the contact conditions (contact site, duration, frequency) remain consistent with the previously cleared devices.
## 8. Clinical Test Conclusion
No clinical study is included in this submission.
## 9. Summary Of Verification And Validation
The manufacturer has performed non-clinical performance testing based on its risk assessment utilizing Failure Mode Effect Analysis (FMEA).
Following Quality System processes, required testing was conducted to validate the cumulative modifications made to the subject devices.
Based on the risk analysis, there is an identification of the verification and/or validation activities required to comply with 21 CFR 820.30.
The manufacturer use outsourced performance testing as verification and/or validation activities.
## 10. Conclusion
The subject device and the predicate device have the same intended use and technological characteristics. All differences have not raised any new safety or effectiveness issues, and the device is substantially equivalent to the approved predicate device (K232199) in terms of core performance, safety standards, and intended use, meeting the core requirement of FDA Special 510(k) that changes do not affect device safety and effectiveness.
