It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Description

The Electrically powered wheelchair is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

It is mainly composed of front wheel, drive wheel, frame, controller (joystick), motor and drive devices, armrest, backrest, seat belt, footrest, battery box and charger.

The device is powered by Li-ion Battery pack (25V 10Ah) with 11.8 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet(100-240V, 50/60Hz) when the device is not in use.

The user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. When the user releases the joystick will automatically go back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

AI/ML Overview

This document is a 510(k) summary for an electrically powered wheelchair (HP202). It focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (K230964) rather than proving the device meets specific acceptance criteria through a clinical study of an AI/software component.

Therefore, the request for details related to AI/software performance evaluation (like acceptance criteria for an AI model, sample sizes for test/training sets, expert consensus, MRMC studies, standalone performance, etc.) cannot be fully answered from the provided text.

The document states: "No clinical study is included in this submission." and primarily relies on non-clinical testing against established ISO standards and direct comparison of specifications to the predicate device to argue for substantial equivalence.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent for AI-specific criteria:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally implied by conformity to specific ISO standards and the performance metrics of the predicate device. The document presents a comparison table (Table 1: General Comparison, and implicitly Table 3: Performance Comparison) rather than a formal acceptance criteria table with a "Pass/Fail" or "Meets" column. The "Remark" or "Results" columns in these tables serve a similar purpose by indicating "S.E." (Substantially Equivalent) or explaining minor differences that do not raise new safety or effectiveness concerns.

Feature/Test	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Subject Device)	Result/Remark
Biocompatibility	Compliance with ISO 10993-5, -10, -23	Compliance with ISO 10993-5, -10, -23	S.E.
EMC	Compliance with ISO 7176-21	Compliance with ISO 7176-21 & IEC 60601-2-1	S.E.
Braking distance	≤ 1.5 m (as per predicate)	≤ 1 m	Minor difference, shorter distance is safer.
Max. safe operational incline	9° (as per predicate)	10°	Minor difference, doesn't raise new safety/effectiveness concerns as stability evaluated per ISO 7176 series.
Max loading weight	110kg (as per predicate)	120kg	Difference on loading weight will not cause different performance; validated with max loading weight.
Max distance of travel	10 km (as per predicate)	11.8 km	Caused by wheel size; farther is better.
Turning Radius	900 mm (as per predicate)	1000 mm	Minor difference due to size, doesn't raise new safety/effectiveness concerns.
Maximum obstacle climbing	40 mm (as per predicate)	20 mm	Minor difference, doesn't raise new safety/effectiveness concerns.
Static stability	Meets ISO 7176-1 requirements	Meets ISO 7176-1 requirements	S.E.
Dynamic stability	Meets ISO 7176-2 requirements	Meets ISO 7176-2 requirements	S.E.
Brake effectiveness	Meets ISO 7176-3 requirements	Meets ISO 7176-3 requirements	S.E.
Energy consumption/Distance range	Meets ISO 7176-4 requirements	Meets ISO 7176-4 requirements	S.E.
Overall dimensions, mass	Meets ISO 7176-5 requirements	Meets ISO 7176-5 requirements	S.E.
Max speed, acceleration, deceleration	Meets ISO 7176-6 requirements	Meets ISO 7176-6 requirements	S.E.
Seating and wheel dimensions	Meets ISO 7176-7 requirements	Meets ISO 7176-7 requirements	S.E.
Static, impact, fatigue strengths	Meets ISO 7176-8 requirements	Meets ISO 7176-8 requirements	S.E.
Climatic tests	Meets ISO 7176-9 requirements	Meets ISO 7176-9 requirements	S.E.
Obstacle-climbing ability	Meets ISO 7176-10 requirements	Meets ISO 7176-10 requirements	S.E.
Test dummies requirements	Meets ISO 7176-11 requirements	Meets ISO 7176-11 requirements	S.E.
Coefficient of friction of test surfaces	Meets ISO 7176-13 requirements	Meets ISO 7176-13 requirements	S.E.
Power and control systems	Meets ISO 7176-14 requirements	Meets ISO 7176-14 requirements	S.E.
Information disclosure, documentation, labeling	Meets ISO 7176-15 requirements	Meets ISO 7176-15 requirements	S.E.
Resistance to ignition of postural support devices	Meets ISO 16840-10 requirements	Meets ISO 16840-10 requirements	S.E.
Batteries and chargers	Meets ISO 7176-25 requirements	Meets ISO 7176-25 requirements	S.E.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided as no clinical study was conducted. The testing described is primarily physical device testing against engineering standards. The manufacturer is based in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided as no clinical study or expert-based ground truth establishment (relevant for AI/image analysis) was performed.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided as no clinical study or expert-based ground truth establishment was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. The device is an electrically powered wheelchair, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance test for an AI algorithm was not performed because the device itself is an electrically powered wheelchair and the submission does not describe an AI algorithm component requiring such testing. The "software validation" mentioned relates to the wheelchair's control system, not an AI for interpretation or diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by conformance to internationally recognized engineering standards (ISO 7176 series, ISO 10993 series) and direct comparison of technical specifications and safety features to a legally marketed predicate device. This is a non-clinical "ground truth."

8. The sample size for the training set

This information is not provided as no AI training set was described or used in this submission.

9. How the ground truth for the training set was established

This information is not provided as no AI training set was described or used in this submission.

In summary: The provided FDA 510(k) summary for the "Electrically powered wheelchair (HP202)" demonstrates substantial equivalence through non-clinical testing against ISO standards and direct comparison to a predicate device. It does not involve a clinical study or the evaluation of an artificial intelligence/software component where the requested details about acceptance criteria, sample sizes, expert ground truth, or human-AI interaction would be relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 17, 2024 Kunshan Hi-Fortune Health Products Co., Ltd % Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K241337

Trade/Device Name: Electrically powered wheelchair (HP202) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 16, 2024 Received: September 16, 2024

Dear Ariel Xiang:

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"

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K241337 - Ariel Xiang

(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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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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Sincerely,

Tushar Bansal -S

for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241337

Device Name

Electrically powered wheelchair

Indications for Use (Describe)

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X 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.

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510(k) Summary K241337

Document Prepared Date: 2024/5/11

Applicant: A. Kunshan Hi-Fortune Health Products Co., Ltd Address:NO.625 Juxiang Road, Zhangpu Town.Kunshan City, Jiangsu ,215321, CHINA Contact Person: Lewis Tian Email:zhanli.tian@hi-fortune.net

Submission Correspondent: Primary contact: Ms.Ariel Xiang Title: Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: shouqiu.xiang@sungoglobal.com

Secondary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: jiawei.wu@sungoglobal.com

B. Device:

Trade Name: Electrically powered wheelchair Common Name: Powered wheelchair Models: HP202

Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine

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C. Predicate device:

510(k) number: K230964 Regulation Number: 890.3860 Classification Name: Powered wheelchair Device Name: Power Wheelchair Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

D. Indications for use of the device:

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

E. Device Description:

It is mainly composed of front wheel, drive wheel, frame, controller (joystick), motor and drive devices, armrest, backrest, seat belt, footrest, battery box and charger.

Non-Clinical Test Conclusion F.

Non-clinical tests were conducted to verify that the proposed 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 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
ISO 10993-10:2021 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And > Skin Sensitization
ISO 10993-23: 2021 Biological evaluation of medical devices Part 23: Tests for irritation >
ISO 7176-1: 2014. Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of Powered Wheelchairs
ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes >
ISO 7176-4, Third edition 2008-10-01, Wheelchairs - Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range

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ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall > dimensions, mass and manoeuvring space
ISO 7176-6: 2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
ISO 7176-7, 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 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs >
ISO 7176-10:2008, Wheelchairs Part 10: Determination of obstacle-climbing ability of > electrically powered wheelchairs
ア ISO 7176-11:2012 Wheelchairs - Part 11: Test dummies.
ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and wheelchairs - Requirements and test methods
ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
ISO 16840-10:2021 Wheelchair seating Part 10: Resistance to ignition of postural support devicesRequirements and test method.
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >
IEC 62133-2: 2017: Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

Clinical Test Conclusion ت

No clinical study is included in this submission.

Comparison with predicate Device H.

Compared to the predicate devices, the subject device has the same intended use, similar product design, similar performance, same safety as the predicate device, the summarized comparison information is listed in the following table

Elements of Comparison	Subject Device	Predicate Device(K230964)	Remark
Manufacturer	Kunshan Hi-FortuneHealth Products Co.,Ltd	Zhejiang InnuovoRehabilitation DevicesCo.,Ltd	--
Common or Usual name	Electrically poweredwheelchair	Power Wheelchair	--
Model(s)	HP202	N5909	--
Classification	Class II	Class II	Same
Classification regulation	21 CFR890.3860	21 CFR890.3860	Same
Product code	ITI	ITI	Same

Indications for use	It is a motor driven,indoor and outdoortransportation vehiclewith the intended use toprovide mobility to adisabled or elderlyperson limited to aseated position.	It is a motor driven,indoor andoutdoortransportationvehiclewith the intended use toprovide mobility to adisabled or elderlyperson limited toaseated position.	S.E.
Use condition	indoor and outdoor use	indoor and outdoor use	S.E
Number of wheels	4,including two frontwheels and two rearWheels	4,including two frontwheels and two rearWheels	S.E
Function of wheels	Front wheels:drivenwheels suitable forrotation, acceleration,retrograde Rear wheels:driving wheels tocontrol the speed anddirection	Front wheels:drivenwheelssuitable forrotation,acceleration,retrograde Rear wheels:drivingwheelstocontrol the speed anddirection	S.E
Movement controlmethod	By Joystick control	By Joystick control	S.E
Driving system	Direct drive on the rearwheels	Direct drive on the rearwheels	S.E
Brake system	Automaticelectromagneticbrake system	Automaticelectromagneticbrake system	S.E
Main frame material	Carbon fiber material	Carbon fiber material	S.E
Folding method	Collapsible cross-brace	Collapsible cross-brace	S.E
Braking distance	≤1 m	≤ 1.5 m	Minor difference onbraking distance willnot cause differentperformance. Shorterdistance for brakingwill be more safety.
Maximumsafeoperational inclinedegree	10°	9 °	Minor difference onsafe operationalincline degree willnot cause new safetyand effectivenessconcerns, as both thestatic and dynamicstability underspecific incliningdegree have beenevaluated accordingto standard ISO 7176series.
Armrest	Carbon fiber material	T700	Different materialused for parts in

Back cushion	comfomesh	Polyester fabric	contact with user,which suchdifferences will not
Seat cushion	comfomesh	rubber patch cloth andOxford fabric	impact the safety andeffectiveness of thesubject device asbiocompatibility testsare carried outaccording to ISO10993 series.
Overall Dimension(lengthwidthheight)	1000580900mm	940610960mm	Minor difference onwheelchair dimensionwill not cause
Folded Dimension(lengthwidthheight)	870280765mm	720310610mm	differentperformance. Allsafety andperformance havebeen validated withthe maximum ratedweight dummy.Analysis
Front wheel size/type	7" PU Solid tire	7" x 1.75"/PU Solid tire	S.E
Rear wheel size/type	10" PU Solid tire	8.5"x 2"/ PU Solid tire	Minor difference ondimension of wheelswill not causedifferentperformance.
Max speed forward	6 km/h (1.6 m/s)	Up to 6 km/h (1.6 m/s),adjustable	S.E
Max Speed backward	0.7 m/s (2.556 km/h)	0.71 m/s (2.556 km/h)	S.E
Max loading weight	120kg (≈265lbs)	110kg (≈250lbs)	Difference on loadingweight will not causedifferentperformance. Allsafety andperformance havebeen validated withthe maximum loadingweight.
Battery	Li-ion battery pack;rechargeable, 24 VDC10Ah	Li-ion battery pack;rechargeable, 24 VDC10Ah	S.E
Battery charger	Off-board chargerInput: 100-240V,50/60Hz, 1.5A,Output: 24 Vdc, 2A;	Off-board chargerInput:100-240V,50/60Hz, 1.5A,Output: 24 Vdc, 2A;	S.E
Maximum distance oftravel on the fully chargedbattery	11.8km	10 km	It is caused by thesize of the wheel, willnot cause differentperformance, The
			further away thebetter.
Motor	Brushless Eco-Drive,24V,150W, 2pcs	Brushless DC motor;24VDC; 150W; 2pcs	S.E
Electronic controller	Brushless dual-driverocker controller	Brushless dual-driverocker controller	S.E
Turning Radius	1000mm	900 mm	Minor difference inturning radius iscaused by differentsize of wheelchairand may
Maximum obstacleclimbing	20 mm	40 mm	Minor difference onobstacle climbing willnot cause new safetyand effectivenessconcerns.

Table 1 General Comparison

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Substantially Equivalence Discussion:

The proposed device and predicate device are complying to the same ISO standards, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-7, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 16840-10, ISO 7176-21, ISO 7176-25, and FDA guidance Submission for Power Wheelchair.

The indications for use for both devices are the same. Mainframes of two devices are and the frame materials are the same carbon fiber. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3. Turning radius, Maximum obstacle climbing and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2 and ISO 7176-10. The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.

The flame-retardant test of the seat cushion/ backrest of both subject device and predicate device is carried out according to the ISO 16840-10 test. Therefore, both devices are assured to be under the same safety level.

In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contactingmaterials are compliance with	All user directly contactingmaterials are compliance with	S.E.

Table 2 Safety comparison

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	ISO10993-5, ISO10993-10 andISO 10993-23 requirements.	ISO10993-5, ISO10993-10 andISO 10993-23 requirements.
EMC	ISO7176-21 & IEC 60601-2-1	ISO7176-21	S.E.
Performance	ISO7176 series	ISO7176 series	S.E.
Labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.

Table 3 Safety comparison

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I. Conclusion

The conclusion drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K230964.

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).

Item	Proposed Device	Predicate Devices	Results
ISO7176-1	The Static stability has been determinedafter the testing according to the ISO7176-1, and test results meet its designspecification.	The Static stability has been determinedafter the testing according to the ISO7176-1, and test results meet its designspecification.	S.E.
ISO7176-2	The dynamic stability has beendetermined after the testing according tothe ISO 7176-2, and test results meet itsdesign specification.	The dynamic stability has beendetermined after the testing according tothe ISO 7176-2, and test results meet itsdesign specification.	S.E.
ISO7176-3	The effectiveness of brakes has beendetermined after the testing according tothe ISO 7176-3, and test results meet itsdesign specification.	The effectiveness of brakes has beendetermined after the testing according tothe ISO 7176-3, and test results meet itsdesign specification.	S.E.
ISO7176-4	The theoretical distance range has beendetermined after the testing accordingto the ISO 7176-4, and test results meetits design specification.	The theoretical distance range has beendetermined after the testing accordingto the ISO 7176-4, and test results meetits design specification.	S.E.
ISO7176-5	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-5	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-5	S.E.
ISO7176-6	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-6	The dimensions, mass has beendetermined after the testing according tothe ISO 7176-6	S.E.
ISO7176-7	The seating and wheel dimensions hasbeen determined after the testingaccording to the ISO 7176-7	The seating and wheel dimensions hasbeen determined after the testingaccording to the ISO 7176-7	S.E.
ISO7176-8	All test results meet therequirements in Clause 4 of ISO7176-8	All test results meet therequirements in Clause 4 of ISO7176-8	S.E.
ISO7176-9	The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9	The test results shown that the deviceunder tests could continue to functionaccording to manufacturer'sspecification after being subjected toeach of the tests specified in Clause 8of ISO 7176-9	S.E.
ISO7176-10	The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10	The obstacle-climbing ability ofdevice has been determined after thetesting according to the ISO 7176-10	S.E.
ISO7176-11	The test dummies used in the testing ofISO 7176 series are meet therequirements of ISO 7176-11	The test dummies used in the testing ofISO 7176 series are meet therequirements of ISO 7176-11	S.E.
ISO7176-13	The coefficient of friction of test surfaceshas been determined, which could beused in other 7176 series tests involved	The coefficient of friction of test surfaceshas been determined, which could beused in other 7176 series tests involved	S.E.
ISO7176-14	All test results meet the requirementsin Clause 7, 8, 9, 10, 11, 12, 13, 14,15, 17 of ISO 7176-14	All test results meet the requirementsin Clause 7, 8, 9, 10, 11, 12, 13, 14,15, 17 of ISO 7176-14	S.E.
ISO7176-15	The test results shown thatinformation disclosure, documentationand labelling of device meet therequirements of ISO 7176-15	The test results shown thatinformation disclosure, documentationand labelling of device meet therequirements of ISO 7176-15	S.E.
ISO7176-16/ISO 16840-10	The performance of resistance toignition meet the requirements ofISO 16840-10	The performance of resistance toignition meet the requirements ofISO 16840-10	S.E.
ISO 7176-21	The EMC performance results meet therequirements of ISO 7176-21	The EMC performance results meet therequirements of ISO 7176-21	S.E.
ISO7176-25	The performance of batteries and chargerof device meet the Requirements inClause 5 and 6 of ISO 7176-25	The performance of batteries and chargerof device meet the Requirements inClause 5 and 6 of ISO 7176-25	S.E.