← Product Code [IOR](/productcode/IOR) · K260145

# YJ-K1K2 Wheelchair (YJ-013F) (K260145)

_Zhenjiang Assure Medical Equipment Co., Ltd. · IOR · Sep 15, 2026 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260145

## Device Facts

- **Applicant:** Zhenjiang Assure Medical Equipment Co., Ltd.
- **Product Code:** [IOR](/productcode/IOR.md)
- **Decision Date:** Sep 15, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 890.3850
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Indications for Use

The YJ-K1K2 Wheelchair(YJ-013F) is to provide mobility to persons limited to a sitting position.

## Device Story

Manual, foldable mechanical wheelchair; provides mobility to users restricted to sitting position. Features main frame, seat, adjustable footrests, four wheels, hand rims for manual propulsion, and brakes. Operated by user or assistant via push handles. Used in indoor/outdoor environments. Provides mobility; facilitates transport via folding mechanism. Benefits patient by enabling independent or assisted movement.

## Clinical Evidence

No clinical data. Bench testing only. Device performance verified against ISO 7176-1, -3, -5, -7, -8, -11, -13, -15, -22, and ISO 16840-10.

## Technological Characteristics

Mechanical wheelchair; steel frame; nylon upholstery; PU armrest padding; aluminum brake/fork; PP/steel handrims. Manual operation; foldable cross-brace design. Dimensions: 990x580x820mm. Weight capacity: 150 lbs. Complies with ISO 7176 series and ISO 16840-10. No electronics or software.

## 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

- YJ-K1/K2 Wheelchair ([K232230](/device/K232230.md))

## Reference Devices

- [K252370](/device/K252370.md)
- [K112948](/device/K112948.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.
>
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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: K260145

Trade/Device Name: YJ-K1K2 Wheelchair (YJ-013F)
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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K260145 - 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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K260145 - 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)
K260145

Device Name
YJ-K1K2 Wheelchair(YJ-013F)

Indications for Use (Describe)
The YJ-K1K2 Wheelchair(YJ-013F) 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

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

# 510(k) Summary

# K260145

## 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: 3 April 2026

## 3. Subject Device Information

Type of 510(k) submission: Special

Trade/Device Name: YJ-K1K2 Wheelchair(YJ-013F)

Regulation Name: Mechanical Wheelchair

Product Code: IOR

Regulation Number: 890.3850

Regulation Class: 1

## 4. Predicate Device Information

Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

1

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

Name of Device: YJ-K1/K2 Wheelchair

Model: YJ-K1F 16" NDE; YJ-K1F 16" NDS; YJ-K1F 18" NDE; YJ-K1F 18" NDS; YJ-K1F 20"

NDE;YJ-K1F 20" NDS;YJ-K1F 18" NDEE;YJK1F 16" VDE;YJ-K1F 16" VDS;YJ-K1F 18"

VDE;YJ-K1F 18" VDS;YJ-K1F 20" VDE;YJ-K1F 20" VDS;YJ-K2 16" VDFE;YJ-K2 16" VDFS;YJ-K2

18" VDFE;YJ-K2 18" VDFS;YJ-K2 20" VDFE;YJ-K2 20" VDFS;YJ-K1G 18" NFFE;YJ-K1G 18"

NFFS;YJ-K2TC 16" NAFE;YJ-K2TC 18" NAFE;YJK2TC 20" NAFE.

Regulation Name: Mechanical Wheelchair

Product Code: IOR

Regulation Number: 890.3850

Regulation Class: 1

510(k) number:K232230

## 5. General Description

The YJ-K1K2 Wheelchair(YJ-013F) are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring 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 manoeuvre 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-013F

### 5.2 Intended Use/Indications For Use

The YJ-K1K2 Wheelchair(YJ-013F) 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, Anti-tipper (selected models), brake extender (selected models).

### 5.4 Human body Contacting Materials

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

|  Patient Contacting Component | Material Name  |
| --- | --- |
|  Frame | Steel  |
|  Seat+Back upholstery | Nylon  |
|  Armrest padded material | PU  |
|  Handrim | Polypropylene (PP)/Steel  |
|  Brake | Aluminum  |
|  Front Fork | Aluminum  |
|  Footplate | Plastic/Aluminum  |
|  Tire | PU  |

5.5 Specification

|   | YJ-013F  |
| --- | --- |
|  Overall length*width*height | 990mm*580mm*820mm  |
|  Folded dimension | 990mm*330mm*610mm  |
|  Seat width | 12" 305mm14" 360mm  |
|  Weight (Total) | 19.15kg  |
|  Weight Capacity | 150LBS  |
|  Seat depth | 340mm  |
|  Backrest angle | 5.5° (fixed, non-adjustable)  |
|  Backrest height | 450mm  |
|  Backrest width | 12" 305mm14" 360mm  |
|  Footrest to seat distance | 350-430mm  |
|  Armrest length | 370mm  |
|  Armrest width | 50mm  |
|  Hand rim diameter | 415mm  |
|  Static stability uphill | 10.00°  |
|  Static stability downhill | 10.00°  |
|  Static stability sideways | 10.20°  |
|  Diameter of front wheels | Φ6X1.25"PU  |
|  Diameter of rear wheels | Φ22" PU  |
|  Uphill holding angle | 7.25°  |
|  Downhill holding angle | 7.20°  |

## 6. Summary of Comparison and Technological Characteristics

Table 1-General Comparison

3

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

|  Elements of Comparison | Predicate Device | Subject Device | Comment  |
| --- | --- | --- | --- |
|  K number | K232230 | 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-K1/K2 Manual Wheelchair is to provide mobility to persons limited to a sitting position. | The YJ-K1K2 Wheelchair(YJ-013F) 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-K1 | YJ-013F | N/A  |
|  Design Characteristic | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to Lock, Armrest, Backrest, Foot rest, skirt guard, Anti-tipper (selected models), brake extender(selected models) | Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to Lock, Armrest, Backrest, Foot rest, skirt guard, Anti-tipper (selected models), brake extender(selected models) | Same  |
|  Brake control | occupant-operated brake only | occupant-operated brake only | Same  |

4

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

|  Operation Environment | For indoor/outdoor use | For indoor/outdoor use | Same  |
| --- | --- | --- | --- |
|  Control Mode | Mechanical | Mechanical | Same  |
|  Size(unfold) | 1220 (L) *660/640/700 (W) *857/908mm (H) | 990mm*580mm*820mm | Note 1  |
|  Stowage length/width/height | 1220(L)*280/285/310(W)*857/908mm(H) | 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 | Φ22" PU | Note 1  |
|  Armrest | Fixed/flip up | Fixed/flip up | Same  |
|  Foot rest | swing away footrest/ elevating leg rest | swing away footrest/ elevating leg rest | Same  |
|  Rear Axle Position | Single | Single | Same  |
|  Safety Feature | Manual Wheel Lock | Manual Wheel Lock | Same  |
|  Braking time | The manual wheelchair brake is mechanical structure and manual braking, and the braking time can be ignored when it is used immediately. | The manual wheelchair brake is mechanical structure and manual braking, and the braking time can be ignored when it is used immediately. | Same  |
|  Braking distance | brake is mechanical structure and manual braking, and the braking distance can be ignored. | brake is mechanical structure and manual braking, and the braking distance can be ignored. | Same  |
|  Frame material | Steel | Steel | Same  |

5

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

|  Seat+Back upholstery | PVC | Nylon | Note 2  |
| --- | --- | --- | --- |
|  Handrim | Plastic/Steel | Polypropylene (PP)/Steel | Note 2  |
|  Armrest padded material | PVC | PU | Note 2  |
|  Brake | Steel | Aluminum | Note 2  |
|  Front Fork | Steel | Aluminum | Note 2  |
|  Footplate | Plastic/Aluminum | Plastic/Aluminum | Same  |
|  Performance | Complywith:ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-16 | Complywith:ISO7176-1ISO7176-3ISO7176-5ISO7176-7ISO7176-8ISO7176-11ISO7176-13ISO7176-15ISO7176-22ISO16840-10 | Similar 1  |
|  Biocompatibility | Comply with:ISO10993-1ISO10993-5ISO10993-10 | Comply with:ISO10993-1ISO10993-5ISO10993-10 | Same  |

#### Note 1

Compared to the predicate device, the subject device has different values on the unfold size, stowage size, device weight, capacity, seat width, backrest width and tire size. However, the subject device has passed ISO 7176-5:2021 (Dimensions, mass and maneuvering space) and ISO 7176-7:1998 (Measurement of seating and wheel dimensions), so the above differences do not raise any new risk of safety or effectiveness.

#### Note 2

6

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

Compared to the predicate device, the subject device has implemented material changes including Seat+back upholstery (Nylon), Armrest padded material (Polyurethane (PU)), Brake material change (Aluminum), Front fork material change (Aluminum), and handrim material (Polypropylene (PP)). However, these differences 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.

The Armrest padded material (Polyurethane (PU)) and the handrim material (Polypropylene (PP)) of the subject device are 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 these materials 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.

# 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 or alternative scientifically valid means.

# Similar 2

The subject device and the predicate device utilize the same patient-contacting materials and contact classification (intact skin). Both devices comply with ISO 10993-1, ISO 10993-5, and ISO 10993-10 for biological evaluation.

7

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

## 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 to the predicate device.

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 editon 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

8

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Sponsor: Zhenjiang Assure Medical Equipment Co., Ltd.

Subject Device: YJ-K1K2 Wheelchair(YJ-013F)

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, polyurethane (PU) for armrest padded material, polypropylene (PP) for the handrim and aluminum for the brake and front fork) have either been previously used in FDA-cleared mechanical wheelchairs (e.g., K252370 and K112948).) under the same regulation and product code, with identical intended use and intact skin contact classification, or are listed (i.e. polypropylene and polyurethane) 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.

## 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 cleared predicate device (K232230) 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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**Source:** [https://fda.innolitics.com/device/K260145](https://fda.innolitics.com/device/K260145)

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