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

This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon fiber. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 136KG. Only for one person sit.

AI/ML Overview

This document is an FDA 510(k) Premarket Notification for a Power Wheelchair (Model N6102). It aims to demonstrate substantial equivalence to a predicate device (K230964). Since this is a submission for a physical medical device (a power wheelchair) and not a software/AI-driven diagnostic or therapeutic device, the concepts of acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and separate training/test sets are not applicable in the context of typical AI/ML device evaluations.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a power wheelchair primarily revolve around compliance with recognized performance and safety standards (ISO 7176 series, IEC 60601-1-2, ISO 10993 series) and demonstrating that any differences from a predicate device do not raise new safety or effectiveness concerns.

Here's how to interpret the provided information in the context of device acceptance, organized to address your prompt's structure where applicable, but noting the non-applicability of certain AI/ML-specific terms:

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

The document provides a comparison of the proposed device against a predicate device, largely referencing compliance with international standards. The "acceptance criteria" are implied by these standards and the "reported device performance" is the statement of compliance or comparison to the predicate.

Acceptance Criteria (Implied by Standard/Predicate)	Reported Device Performance (Subject Device)	Discussion/Remark (from document)
General Characteristics
Classification	Class II	Same
Product Code	ITI	Same
Indications for Use	Motor driven, indoor/outdoor transportation for disabled/elderly limited to seated position.	S.E. (Substantially Equivalent)
Intended User	Disabled or elderly person limited to a seated position.	S.E.
Use Condition	Indoor and outdoor use	S.E.
Driving System	Direct drive on the rear wheels	S.E.
Brake System	Automatic electromagnetic brake system	S.E.
Armrest Material	T700 (Predicate)	Carbon fibers
Main Frame Material	Carbon fiber material	Carbon fiber material
Back Cushion Material	Polyester fabric (Predicate)	Polyester fiber
Seat Cushion Material	Polyester fiber	Polyester fiber
Number of Wheels	4 (two front, two rear)	4 (two front, two rear)
Function of Wheels	Front: driven for rotation, acceleration, retrograde; Rear: driving for speed/direction.	Same
Movement Control	By Joystick control	By Joystick control
Battery (Type & Specs)	li-ion battery pack, 24V, 10Ah	li-ion battery pack, 24V, 10Ah
Battery Charger (Type & Specs)	Off-board, Input: 100-240V, 50/60Hz, 1.5A; Output: 24Vdc, 2A	Same
Motor (Type & Specs)	Brushless DC motor; 24VDC; 150W; 2pcs	Brushless Eco-Drive, 24V, 150W, 2pcs
Electronic Controller	Brushless dual-drive rocker controller	Brushless dual-drive rocker controller
Turning Radius	900mm	900mm
Performance Characteristics
Braking Distance	≤1.5 m (Predicate)	780mm
Maximum Safe Operational Incline Degree	9°	9°
Overall Dimension (LWH)	900580860mm (Predicate)	950610960mm
Front Wheel Size/Type	7" x 1.75"/PU Solid tire (Predicate)	7" x 1.78"/PU Solid tire (180mm x 45mm)
Rear Wheel Size/Type	8.5" x 1.8"/PU Solid tire (Predicate)	9" x 2"/PU Solid tire (230mm x 50mm)
Max Speed Forward	Up to 6 km/h (1.6 m/s), adjustable (Predicate)	1.54 m/s (5.5km/h)
Max Loading Weight	110kg (≈250lbs) (Predicate)	136kg (≈300lbs)
Maximum Distance of Travel on Fully Charged Battery	10 km (Predicate)	16.1km
Maximum Obstacle Climbing	40 mm (Predicate)	25mm
Safety & Compliance (Implied by Standards)
Biocompatibility	ISO10993-5, ISO10993-10, ISO10993-23 requirements	Compliance with ISO10993-5, ISO10993-10, ISO10993-23
EMC Performance	ISO7176-21 and IEC 60601-1-2	Compliant with ISO7176-21 and IEC 60601-1-2
General Performance	ISO7176 series	Compliant with ISO7176 series
Label and Labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory
Specific ISO Standard Compliance
ISO 7176-1 (Static Stability)	Meets design specification	Meets design specification
ISO 7176-2 (Dynamic Stability)	Meets design specification	Meets design specification
ISO 7176-3 (Brakes Effectiveness)	Meets design specification	Meets design specification
ISO 7176-4 (Theoretical Distance Range)	Meets design specification	Meets design specification
ISO 7176-5 (Dimensions, Mass)	Determined/Meets	Determined/Meets
ISO 7176-6 (Dimensions, Mass)	Determined/Meets	Determined/Meets
ISO 7176-7 (Seating & Wheel Dimensions)	Determined/Meets	Determined/Meets
ISO 7176-8 (Requirements)	All test results meet requirements	All test results meet requirements
ISO 7176-9 (Dynamic Tests)	Continue to function after tests	Continue to function after tests
ISO 7176-10 (Obstacle-climbing ability)	Determined/Meets	Determined/Meets
ISO 7176-11 (Test Dummies)	Meet requirements	Meet requirements
ISO 7176-13 (Coefficient of Friction)	Determined for use in other 7176 series tests	Determined for use in other 7176 series tests
ISO 7176-14 (Requirements)	All test results meet requirements	All test results meet requirements
ISO 7176-15 (Information Disclosure, Labeling)	Meets requirements	Meets requirements
ISO 16840-10:2021 (Fire Resistance)	Performance meets requirements	Performance meets requirements
ISO 7176-25 (Batteries and Charger)	Performance meets requirements	Performance meets requirements

2. Sample sizes used for the test set and the data provenance

This information is not provided as it's not relevant for a direct testing of a physical device against standards (e.g., you test a specific number of manufactured units or prototypes for compliance, not a "data set"). The provenance isn't applicable in the same way either; the tests are performed on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of device performance is established by the specified ISO standards and validated test methods (e.g., a test rig for stability or braking) and direct measurements. It doesn't rely on expert consensus in the same way an AI diagnostic image reading might.

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

Not applicable. As above, the "truth" is determined by objective measurements against engineering standards, not through a consensus of human interpretative results.

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

Not applicable. This study is for a physical power wheelchair, not an AI software. There are no "human readers" or "AI assistance" in its intended function or evaluation.

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

Not applicable. This device does not contain an algorithm in this context. Its "performance" is mechanical and electrical, not computational.

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

The "ground truth" for this device's performance is derived from:

International Standards: Primarily the ISO 7176 series, IEC 60601-1-2, and ISO 10993 series, which define objective test methods and acceptable performance limits for wheelchairs.
Engineering Specifications: The design specifications for the device itself (e.g., max speed, loading weight, dimensions).
Physical Testing: Direct physical measurements and tests on the device (e.g., dynamic stability tests, braking distance tests, obstacle climbing tests).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. See point 8.

In summary, the "study" proving the device meets the "acceptance criteria" is a series of engineering tests and analyses demonstrating compliance with relevant international performance and safety standards for power wheelchairs, and a comparison to a legally marketed predicate device to demonstrate substantial equivalence. The differences noted (e.g., slightly different dimensions, braking distance, max loading weight, travel distance, obstacle climbing) are all deemed not to raise new safety or effectiveness concerns, with testing conducted to confirm compliance with the applicable standards even with these differences (e.g., "All safety and performance have been validated with the maximum rated weight dummy").

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

November 27, 2024

Zhejiang Zhonglei Medical Technology Co. Ltd. Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K242308

Trade/Device Name: Power wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: October 30, 2024 Received: October 30, 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.

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Page

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality 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 QS 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 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-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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather L. Dean -S

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

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Indications for Use

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

Submission Number (if known)

K242308

Device Name

Power 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.

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."

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510(K) Summary

Document Prepared Date: 2024/10//30

A. Applicant

Name : Zhejiang Zhonglei Medical Technology Co.Ltd Address : 1st floor, 2nd floor, No. 66, Dayuan Street, Nanmingshan Street, Liandu District, Lishui City, Zhejiang Province, China. Contact Person: Chengwei Ying Tel: +86 13958430301 Mail:594506983@gq.com

Submission Correspondent: Primary contact: Ms. Ariel Xiang Title: Senior 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. Raymond Luo Title: Technical Director Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com

B. Device

Trade Name: Power wheelchair Common Name: Powered wheelchair Models: N6102

Regulatory Information Classification Name: Powered Wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860

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Review Panel: Physical Medicine

C. Predicate device:

510Knumber: K230964 Device Name:Power Wheelchair Manufacturer:Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

Indications for use of the device D.

The Power wheelchair 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

The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of the device is carbon fiber. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.

The DC brushless motor and brake system are fixed on the rear wheels.

The max loading of the device is 136KG. Only for one person sit.

F. Comparison with predicate Device

Table 1 General Comparison
----------------------------

Elements of Comparison	Subject Device	Predicate Device(K230964)	Remark
Manufacturer	Zhejiang Zhonglei	Zhejiang Innuovo	--

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	MedicalTechnology Co.Ltd	RehabilitationDevices Co.,Ltd		Driving system	Direct drive on therearwheels	Direct drive on therearwheels	S.E
Common or Usual name	Power Wheelchair	Power Wheelchair	--	Brake system	Automaticelectromagneticbrake system	Automaticelectromagneticbrake system	S.E
Model(s)	N6102	N5909	--	Braking distance	780mm	≤1.5 m	Minor differenceon brakingdistance will notcause differentperformance.Shorter distancefor braking will bemore safety.
Classification	Class II	Class II	Same	Maximum safeoperationalinclinedegree	9 °	9 °	S.E
Classification regulation	21 CFR890.3860	21 CFR890.3860	Same	Armrest	Carbon fibers	T700	Different materialused for parts incontact with user,which suchdifferences will notimpact the safetyand effectivenessof the subjectdevice asbiocompatibilitytests are carriedout according toISO 10993 series.
Product code	ITI	ITI	Same	Main frame material	Carbon fibermaterial	Carbon fibermaterial	S.E
Indications for use	It is a motordriven, indoor andoutdoortransportationvehicle with theintended use toprovide mobility toa disabled orelderly personlimited to a seatedposition.	It is a motordriven, indoor andoutdoortransportationvehicle with theintended use toprovide mobility toa disabled orelderly personlimited to a seatedposition.	S.E.	Back cushion	Polyester fiber	Polyester fabric	S.E
Intended user	disabled or elderlyperson limited to aseated position.	disabled or elderlyperson limited to aseated position.	S.E.	Seat cushion	Polyester fiber	Polyester fiber	S.E
Use condition	indoor and outdooruse	indoor and outdooruse	S.E	Overall Dimension(lengthwidthheight)	950610960mm	900580860mm	Minor differenceon wheelchairdimension will not
Number of wheels	4,including twofront wheels andtwo rear Wheels	4,including twofront wheels andtwo rear Wheels	S.E
Function of wheels	Frontwheels:driven wheelssuitable forrotation,acceleration,retrograde Rearwheels: drivingwheels to controlthe speed anddirection	Frontwheels:driven wheelssuitable forrotation,acceleration,retrograde Rearwheels: drivingwheels to controlthe speed anddirection	S.E
Movement control	By Joystick control	By Joystick control	S.E

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(lengthwidthheight)			cause differentperformance. Allsafety andperformance havebeen validatedwith the maximumrated weightdummy.Analysis
Front wheel size/type	7" x1.78"/ PUSolid tire(180mmx45mm)	7" x 1.75"/PU Solidtire	Minor differenceon dimension ofwheels will notcause differentperformance.
Rear wheel size/type	9" x 2"/PU Solidtire(230mmx50mm)	8.5" x 1.8"/ PUSolid tire	Minor differenceon dimension ofwheels will notcause differentperformance.
Max speed forward	1.54 m/s (5.5km/h)	Up to 6 km/h (1.6m/s), adjustable	Minor differenceon Max speedforward of wheelswill not causedifferentperformance.
Max loading weight	136kg (≈300lbs)	110kg (≈250lbs)	Difference onloading weight willnot cause differentperformance. Allsafety andperformance havebeen validatedwith the maximumloading weight.
Maximum distance oftravel on the fully chargedbattery	16.1km	10 km	It is caused by thesize of the wheel,will not causedifferentperformance, Thefurther away thebetter
Battery
	li-ion battery pack24V,10Ah,	li-ion battery packrechargeable, 24 VDC 10Ah	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
Motor	Brushless Eco-Drive,24V,150W, 2pcs	Brushless DC motor; 24VDC; 150W; 2pcs	S.E
Electronic controller	Brushless dual-drive rocker controller	Brushless dual-drive rocker controller	S.E
Turning Radius	900mm	900 mm	S.E
Maximum obstacle climbing	25mm	40 mm	Minor difference on obstacle climbing will not cause new safety and effectiveness concerns.

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Table 2 safety comparison

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G. Substantial Equivalence Discussion

The subject device complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2008, ISO7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2: 2014.

The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close.

The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14:2008. 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 7176-3:2012.

Turning radius and Maximum obstacle climbing 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 7176-2:2001, ISO 7176-10:2008.

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

The all rest different between the subject device and predicate device can proved the safety or effectiveness by the ISO 7176 series support reports.

Different material used for parts in contact with user, which such differences will not impact the safety and effectiveness of the subject device as biocompatibility tests are carried out according to ISO 10993 series.

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.

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H. Substantially Equivalency Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices, K230964 Power Wheelchair from Zhejiang Innuovo Rehabilitation Devices Co., Ltd.

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 Device	Results
Biocompatibility	All user directly contactingmaterials are compliancewithISO10993-5 ,ISO10993-10,ISO10993-23 requirements.	All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements.	S.E.
EMC	ISO7176-21 and IEC 60601-1-2	ISO7176-21 and IEC 60601-1-2	S.E.
Performance	ISO7176 series	ISO7176 series	S.E.
Label andlabeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.
Item	Proposed Device	Predicate Device	Results
ISO7176-1	The Static stability has beendetermined after the testingaccording to the ISO 7176-1,and test results meet itsdesign specification.	The Static stability has beendetermined after the testingaccording to the ISO 7176-1,and test results meet itsdesign specification.	S.E.
ISO7176-2	The dynamic stability hasbeen determined after thetesting according to the ISO7176-2, and test results meetits design specification.	The dynamic stability hasbeen determinedafter the testing according tothe ISO 7176-2, and testresults meet its designspecification.	S.E.
ISO7176-3	The effectiveness of brakeshas been determined after thetesting according to the ISO7176-3, and test results meetits design specification.	The effectiveness of brakeshas beendetermined after the testingaccording to the ISO 7176-3,and test results meet itsdesign specification.	S.E.
ISO7176-4	The theoretical distance rangehas been determined afterthe testing according to theISO 7176-4, and test resultsmeet its design specification.	The theoretical distance rangehas been determined afterthe testing according to theISO 7176-4, and test resultsmeet its design specification.	S.E.
ISO7176-5	The dimensions, mass hasbeen determined after thetesting according to the ISO7176- 5.	The dimensions, mass hasbeen determined after thetesting according to the ISO7176- 5.	S.E.
ISO7176-6	The dimensions, mass hasbeen determined after thetesting according to the ISO7176- 5.	The dimensions, mass hasbeen determined after thetesting according to the ISO7176- 5.	S.E.
ISO7176-7	The seating and wheeldimensions has beendetermined after the testingaccording to the ISO 7176-7.	The seating and wheeldimensions has beendetermined after the testingaccording to the ISO 7176-7.	S.E.
ISO7176-8	All test results meet therequirements in Clause 4 ofISO 7176-8.	All test results meet therequirements in Clause 4 ofISO 7176-8.	S.E.
ISO7176-9	The test results shown thatthe device under tests couldcontinue to function accordingto manufacturer's specificationafter being subjected to eachof the testsspecified in Clause8 of ISO 7176-9.	The test results shown that thedevice under tests couldcontinue to function accordingto manufacturer's specificationafter being subjected to eachof the tests specified in Clause8 of ISO 7176-9.	S.E.
ISO7176-10	The obstacle-climbing abilityof device has beendetermined after the testingaccording to the ISO 7176-10.	The obstacle-climbing abilityof device has been determinedafter the testing according tothe ISO 7176-10.	S.E.
ISO7176-11	The test dummies used in thetesting of ISO 7176 series aremeet the requirements of ISO7176-11.	The test dummies used in thetesting of ISO 7176 series aremeet the requirements of ISO7176-11.	S.E.
ISO7176-13	The coefficient of friction oftest surfaces has beendetermined, which could beused in other 7176 series testsinvolved.	The coefficient of friction oftest surfaces has beendetermined, which could beused in other 7176 series testsinvolved.	S.E.
ISO7176-14	All test results meet therequirements in Clause 7, 8, 9,10, 11, 12, 13, 14, 15, 17 ofISO 7176-14.	All test results meet therequirements in Clause 7, 8, 9,10, 11, 12, 13, 14, 15, 17 ofISO 7176-14.	S.E.
ISO7176-15	The test results shown thatinformation	The test results shown thatinformation	S.E.
	disclosure, documentationand labelling of device meetthe requirements of ISO7176-15.	disclosure, documentation andlabelling of device meet therequirements of ISO7176-15.
ISO16840-10:2021	The performance of resistancetoignition meet the requirements	The performance of resistancetoignition meet the requirements	S.E.
	of ISO 16840-10:2021.	of ISO 16840-10:2021.
ISO 7176-21/IEC60601-1-2	The EMC performance resultsmeet the requirements of ISOIEC60601-1-2.	The EMC performance resultsmeet the requirements of ISO7176-21&IEC60601-1-2.	S.E.
ISO7176-25	The performance of batteriesand charger of device meetthe Requirements in Clause 5and 6 of ISO 7176-25.	The performance of batteriesand charger of device meetthe Requirements in Clause5and 6 of ISO 7176-25.	S.E.