Reclining wheelchair (YJ-013L)
Device Facts
| Record ID | K260144 |
|---|---|
| Device Name | Reclining wheelchair (YJ-013L) |
| 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 Reclining wheelchair(YJ-013L) is to provide mobility to persons limited to a sitting position.
Device Story
Manual, foldable, mechanical wheelchair; intended for indoor/outdoor use on level surfaces. Features main frame, seat, backrest, adjustable footrests, four wheels (front swivel, rear with hand rims), and occupant-operated brakes. Operated by user or assistant via push handles. Provides mobility by allowing user to maneuver via hand rims or assistant to push. Reclining backrest (7-88°) adjusts posture. Device folds for transport. Benefits include improved mobility for individuals with limited sitting capacity.
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 demonstrated structural integrity, stability, brake effectiveness, and ignition resistance using worst-case configuration (14" seat width, 88° recline, 150 lbs load).
Technological Characteristics
Mechanical, manual wheelchair. Materials: Steel frame, Nylon upholstery, Aluminum brakes/forks, Polypropylene/Steel handrims, PU tires. Dimensions: 990x580x820mm. Foldable cross-brace design. Standards: ISO 7176 series (stability, dimensions, strength, brakes), ISO 16840-10 (ignition resistance). No electronics or software.
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
- Reclining wheelchair (K232198)
Reference Devices
Submission Summary (Full Text)
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**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: K260144
Trade/Device Name: Reclining wheelchair (YJ-013L)
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
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K260144 - 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).
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K260144 - Eric Shi
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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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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)
K260144
Device Name
Reclining wheelchair (YJ-013L)
Indications for Use (Describe)
The Reclining wheelchair(YJ-013L) 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.**
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
# 510(k) Summary
# K260144
## 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 10, 2026
## 3. Subject Device Information
Type of 510(k) submission: Special
Trade/Device Name: Reclining wheelchair(YJ-013L)
Regulation Name: Mechanical Wheelchair
Product Code: IOR
Regulation Number: 21 CFR 890.3850
Regulation Class: 1
## 4. Predicate Device Information
Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Name of Device: Reclining wheelchair
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
Common Name: Manual Wheelchair
Model(s): YJ-011S 16"D, YJ-011S 16"DF, YJ-011S 18"D, YJ-011S 18"DF, YJ-011S 20"D, YJ-011S
20"DF
Regulation Name: Mechanical Wheelchair
Product Code: IOR
Regulation Number: 21 CFR 890.3850
Regulation Class: 1
510(k) number: K232198
## 5. General Description
The YJ-013L 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 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-013L
### 5.2 Intended Use/Indications For Use
The Reclining wheelchair (YJ-013L) 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, footplates, brake, leg rest.
The device can be operated indoors, or outdoors on dry, levelsurfaces composed of concrete, blacktop, or asphalt under normal driving conditions.
### 5.4 Human body Contacting Materials
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
| Patient Contacting Component | Material Name |
| --- | --- |
| Frame | Steel |
| Seat +Back upholstery | Nylon |
| Handrim | Polypropylene (PP)/Steel |
| Brake | Aluminum |
| Front Fork | Aluminum |
| Footplate | Plastic/Aluminum |
| Tire | PU |
5.5 Specification
| | YJ-013L |
| --- | --- |
| Overall length*width*height | 990mm*580mm*820mm |
| Folded dimension | 990mm*330mm*610mm |
| Seat width | 12" 305mm14" 360mm |
| Weight (Total) | 19.15kg |
| Weight Capacity | 150 LBS |
| Mass of heaviest part | 15.85 kg |
| Seat surface height (front edge) | 390 mm |
| Turning diameter | 2200 mm |
| Ground clearance | 43 mm |
| Seat depth | 340mm |
| Backrest angle | 7-88° (tested at the worst-case 88° fully reclined position) |
| Backrest height | 450mm |
| Backrest width | 12" 305mm14" 360mm |
| Footrest to seat distance | 350-430mm |
| Armrest length | 370mm |
| Armrest width | 50mm |
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
| Hand rim diameter | 415mm |
| --- | --- |
| Static stability uphill | 10.10" |
| Static stability downhill | 10.00" |
| Static stability sideways | 10.00" |
| Diameter of front wheels | Φ6X1.25"PU |
| Diameter of rear wheels | Φ20" PU |
| Uphill holding angle | 7.10° |
| Downhill holding angle | 7.00° |
Note: All performance tests were conducted on the 14" (360 mm) seat width configuration with the backrest set at the worst-case fully reclined angle of 88° which represents the most demanding condition for stability, structural strength, and brake effectiveness. Test results are applicable to both seat width options (12" and 14") and the entire backrest angle range (7-88°).
### 6. Summary of Comparison and Technological Characteristics
Table 1-General Comparison
| Elements of Comparison | Predicate Device | Subject Device | Comment |
| --- | --- | --- | --- |
| K number | K232198 | N/A | N/A |
| Manufacturer | Zhenjiang Assure Medical device Co., Ltd | Zhenjiang Assure Medical device Co., Ltd | Same |
| Proprietary Name | Reclining wheelchair | Reclining 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-011S Manual Wheelchair is to provide mobility to persons limited to a sitting position. | The Reclining wheelchair(YJ-013L) is to provide mobility to persons limited to a sitting Position. | Same |
Table 2 Performance And Safety Comparison
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**Sponsor:** Zhenjiang Assure Medical Equipment Co., Ltd.
**Subject Device:** Reclining wheelchair(YJ-013L)
| Elements of Comparison | Predicate Device | Subject Device | Comment |
| --- | --- | --- | --- |
| Model | YJ-011S | YJ-013L | N/A |
| Design Characteristic | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to Lock, Armrest, Backrest, Foot rest, skirt guard | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to Lock, Armrest, Backrest, Foot rest, skirt guard | Same |
| 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) | 1340 (L)* 1258 (H) *16' 625mm(W) *18' 675mm(W) *20' 725mm(W) | 990mm*580mm*820mm | Note 1 |
| Stowage length/width/height | 1340 (L)* 1258 (H)*323mm(W) | 990mm*330mm*610mm | Note 1 |
| Weight (Total) | 25.5kg | 19.15kg | Note 1 |
| Weight Capacity | 300LBS | 150LBS | Note 1 |
| Seat width | 410-510mm | 305-330mm | Note 1 |
| Backrest width | 410-510mm | 305-330mm | Note 1 |
| Seat depth | 460mm | 340mm | Note 1 |
| Front wheel | Φ8X1'PVC | Φ6X1.25'PU | Note 1 |
| Rear wheels | Φ24' PU | Φ20' PU | Note 1 |
| Armrest | fixed | fixed | Same |
| Foot rest | Optional/ swing away Optional/ swing away | Optional/ swing away Optional/ swing away | Same |
| Rear Axle Position | Single | Single | Same |
5
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
| Rear wheel assembly method | Fixed | Quick release | Note 3 |
| --- | --- | --- | --- |
| Frame material | Steel | Steel | Same |
| Seat +Back upholstery | PVC | Nylon | Note 2 |
| Handrim | Plastic/Steel | Polypropylene (PP)/Steel | Note 2 |
| Brake | Steel | Aluminum | Note 2 |
| Front Fork | Steel | Aluminum | Note 2 |
| Footplate | Plastic/Aluminum | Plastic/Aluminum | Same |
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
| Performance | Complywith: | Complywith: | Similar 1 |
| --- | --- | --- | --- |
| | 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 | ISO7176-15 | |
| | ISO7176-16 | ISO16840-10 | |
| | ISO7176-22 | ISO7176-22 | |
| Biocompatibility | Comply with: | Comply with: | Same |
| | ISO10993-1 | ISO10993-1 | |
| | ISO10993-5 | ISO10993-5 | |
| | ISO10993-10 | ISO10993-10 | |
#### Note 1
Compared to the predicate device, the subject device has different values for unfold size, stowage size, device weight, capacity, seat width, backrest width and tire size. However, the subject has passed the ISO 7176-7:1998 (Measurement of seating and wheel dimensions) and ISO 7176-5:2021 (Determination of dimensions, mass and maneuvering space). All performance tests were conducted on the 14" (360 mm) seat width configuration with the backrest set at the worst-case fully reclined angle of 88° which represents the most demanding condition for stability, structural strength, and brake effectiveness. Therefore, the test results are applicable to both seat width options (12" and 14") and the entire backrest angle range (7-88°). Consequently, the above differences do not raise any new risk of safety or effectiveness.
#### Note 2
Compared to the predicate device, the subject device has implemented material changes to including Seat/back upholstery (Nylon), Brake material (Aluminum), Front fork material (Aluminum), and handrim material (Polypropylene (PP)).
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
However, these difference does not impact safety and effectiveness of the subject device..The Nylon and Aluminum materials have been previously incorporated in FDA-cleared mechanical wheelchairs approved under the same regulation (21 CFR 890.3850) and product code IOR, with similar intended use and technology (e.g.,K252370 and K112948) The contact classification of these changed components remains intact skin contact without any change in the nature, duration and degree of human body contact. 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.
The handrim material (Polypropylene (PP)) of the subject device 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.
# Note 3
Compared to the predicate device, the subject device's rear wheel assembly method is adjustable. These differences will not raise any new risk of safety or effectiveness.
# Similar 1
ISO 7176-16:2012 was withdrawn and replaced by ISO 16840-10:2021, so ISO 7176-16:2012 is therefore no longer valid, nor recognized by FDA. Therefore, to establish adequate fire resistance (and thus, overall safety) of your device in support of substantial equivalence, we have provided additional information and/or rationale to demonstrate adequate resistance to ignition of the postural support components of your device, in accordance with ISO 16840-10:2021. The ignition resistance test was performed on the nylon upholstery material using the heating cartridge method. No flaming was observed during or after the test, and no progressive smouldering was observed 120 seconds after the end of the maximum temperature plateau. The material passes the requirement.
## 7. Summary of Non-Clinic Performance Testing
### 7.1 Bench Performance
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
Non-clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device.
All performance testing was performed on the 14" (360 mm) seat width configuration with the backrest set at the worst-case fully reclined angle of 88° and a load of 150 LBS (68 kg) using the appropriate ISO 7176-11 test dummy. This configuration represents the most demanding condition for stability, structural integrity, and brake effectiveness, thereby validating all available seat width options and the entire backrest angle range.
Test Setup Description: The wheelchair was configured with the 14" seat width, backrest fully reclined to 88°, and loaded to the maximum user weight of 150 LBS using the ISO 7176-11 test dummy. All adjustable components were set to their most demanding positions based on engineering analysis. A single representative sample of the YJ-013L model was tested for each standard, as the device is mechanically symmetrical and the 14" configuration represents the worst-case condition for all performance parameters.
The test results, summarized in the table below, demonstrate full compliance with all applicable standards. Each test included pre-defined acceptance criteria, and all results met or exceeded the requirements.
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
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**Sponsor:** Zhenjiang Assure Medical Equipment Co., Ltd.
**Subject Device:** Reclining wheelchair(YJ-013L)
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
Detailed summary test reports for each ISO standard, containing all six elements required by FDA's Guidance on Non-Clinical Bench Performance Testing (test performed, objective, test method description with sample size and device configuration, pre-defined pass/fail criteria, summary of results, and discussion and conclusions), are provided in the separate document titled "ISO Standard Test Report Summaries-Reclining wheelchair YJ-013L.docx".
## 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 (nylon for seat/back upholstery, polypropylene (PP) for the handrim, and aluminum for front fork and brake) have either been previously used in FDA-cleared mechanical wheelchairs (e.g., K252370, K112948) under the same regulation and product code, with identical intended use and intact skin contact classification , 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 biocompatibility risks are introduced by these material changes, as the contact conditions (contact site, duration, frequency) remain consistent with the previously cleared devices.
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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.
Subject Device: Reclining wheelchair(YJ-013L)
### 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 (K232198) 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.
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