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 Electric Wheelchair (JLE-W01A-2023), is a motor driven, indoor and outdoor 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.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box, charger and anti-tip wheels.

The device is powered by Li-ion Battery pack with 27.5 Km range, which can be recharged by an offboard battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return 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.

Anti-tip wheel is a safety device to prevent the wheelchair from turning over when driving on the slope. When the operator needs to use the subject electric wheelchair, he must pull down the anti-tip wheels.

AI/ML Overview

This document is a 510(k) summary for an Electric Wheelchair (JLE-W01A-2023). It describes the device, its intended use, and substantial equivalence to a predicate device (K220747).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Electric Wheelchair are primarily based on compliance with various ISO standards for wheelchairs and related components, as well as biocompatibility and EMC standards. The reported device performance is that the device "meets its design specification" or "meets the requirements" of these standards.

Acceptance Criteria (Standard)	Description of Criterion	Reported Device Performance (JLE-W01A-2023)
Biocompatibility
ISO 10993-5: 2009	Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity	All user directly contacting materials are in compliance with ISO10993-5 requirements.
ISO 10993-10: 2021	Biological Evaluation of Medical Devices Part 10: Tests For Irritation And Skin Sensitization	All user directly contacting materials are in compliance with ISO10993-10 requirements.
ISO 10993-23: 2021	Biological evaluation of medical devices - Part 23: Tests for irritation	All user directly contacting materials are in compliance with ISO 10993-23 requirements.
Wheelchair Performance
ISO 7176-1: 2014	Wheelchairs - Part 1: Determination of static stability	The static stability has been determined after the testing according to ISO 7176-1, and test results meet its design specification.
ISO 7176-2: 2017	Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs	The dynamic stability has been determined after the testing according to ISO 7176-2, and test results meet its design specification.
ISO 7176-3: 2012	Wheelchairs - Part 3: Determination of effectiveness of brakes	The effectiveness of brakes has been determined after the testing according to ISO 7176-3, and test results meet its design specification. (Note: Braking distance of 1.2m stated in comparison table).
ISO 7176-4: 2008	Wheelchairs Part 4: Energy consumption of electric wheelchairs and wheelchairs for determination of theoretical distance range	The theoretical distance range has been determined after the testing according to ISO 7176-4, and test results meet its design specification. (Note: Max distance of travel on fully charged battery: 27.5 km stated in comparison table).
ISO 7176-5: 2008	Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space	The dimensions, mass has been determined after the testing according to ISO 7176-5. (Note: Overall and Folded dimensions, and Turning Radius stated in comparison table).
ISO 7176-6: 2018	Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs	The dimensions, mass has been determined after the testing according to ISO 7176-6. (Note: Max speed forward and backward stated in comparison table).
ISO 7176-7	Wheelchairs - Part 7: Measurement of seating and wheel dimensions	The seating and wheel dimensions has been determined after the testing according to ISO 7176-7. (Note: Wheel sizes stated in comparison table).
ISO 7176-8: 2014	Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths	All test results meet the requirements in Clause 4 of ISO 7176-8.
ISO 7176-9: 2009	Wheelchairs Part 9: Climatic tests for Powered Wheelchairs	The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9.
ISO 7176-10: 2008	Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs	The obstacle-climbing ability of device has been determined after the testing according to ISO 7176-10. (Note: Maximum obstacle climbing of 35mm stated in comparison table).
ISO 7176-11: 2012	Wheelchairs Part 11: Test dummies	The test dummies used in the testing of ISO 7176 series meet the requirements of ISO 7176-11.
ISO 7176-13: 1989	Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces	The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved.
ISO 7176-14: 2008	Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and wheelchairs - Requirements and test methods	All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14.
ISO 7176-15: 1996	Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling	The test results shown that information disclosure, documentation and labeling of device meet the requirements of ISO 7176-15. (Also stated: Conforms to FDA Regulatory).
ISO 16840-10: 2021 (or ISO 7176-16)	Wheelchair seating Part 10: Resistance to ignition of postural support devices Requirements and test method. (Note: Predicate refers to ISO 7176-16).	The performance of resistance to ignition meet the requirements of ISO 16840-10.
Electromagnetic Compatibility
ISO 7176-21: 2009 / IEC 60601-1-2	Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers	The EMC performance results meet the requirements of ISO 7176-21 and IEC 60601-1-2.
Battery and Charger
ISO 7176-25: 2022	Wheelchairs Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements and test methods (Note: The proposed device uses Li-ion battery, but the standard title mentions Lead-acid. It's likely the standard covers general battery/charger safety).	The Lead-acid batteries and chargers results meet the requirements of ISO 7176-25.
IEC 62133-2	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	The device complies with IEC 62133-2. (Specifically for the Li-ion battery).

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample size used for the test set in the non-clinical tests. It indicates that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and mentions "test records" and "test results" without quantifying the number of devices or components tested.

The data provenance is from China, as the applicant (Zhejiang Jianrui Technology Company Limited) is located in Jinhua City, Zhejiang Province, China, and the tests were conducted to support their 510(k) submission to the FDA. The tests are prospective in nature, as they were conducted on the specific device to demonstrate its performance against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for these types of device performance tests is established by adherence to globally recognized engineering and medical device safety standards (like the ISO 7176 series and ISO 10993 series). The standards themselves define the test methodologies and acceptance criteria. The execution and interpretation of these tests are typically performed by qualified test engineers and technicians at accredited testing laboratories, rather than by medical "experts" in the clinical sense to establish a "ground truth."

4. Adjudication Method for the Test Set

This is not applicable for the type of non-clinical, standards-based testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation studies where expert consensus is needed to establish a definitive diagnosis or assessment for a complicated case. Here, the "adjudication" is implicitly covered by the adherence to the published test methodologies and criteria of the ISO/IEC standards.

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

An MRMC study was not done. This submission is for an Electric Wheelchair, a physical medical device. It does not involve AI or human readers for diagnostic interpretation, so an MRMC comparative effectiveness study is not relevant.

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

This is not applicable. The device is an Electric Wheelchair and does not feature an AI algorithm that would have standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance and safety tests is based on compliance with established international standards (ISO 7176 series, ISO 10993 series, IEC 62133-2). These standards define objective, measurable parameters and acceptable limits for various aspects of the device's function, stability, safety, and biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. The Electric Wheelchair is a physical device and not a machine learning or AI model, so there is no "training set" in the context of data.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set for this device.

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".

August 7, 2024 Zhejiang Jianrui Technology Company Limited % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China

Re: K240255

Trade/Device Name: Electric Wheelchair (JLE-W01A-2023) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 2, 2024 Received: July 2, 2024

Dear Jarvis Wu:

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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(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.

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).

Sincerely.

Julia E. Slocomb - 2024.08.07 13:54:28 -04'00' റ for Tushar Bansal, PhD Team Lead, 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

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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)

K240255

Device Name

Electric Wheelchair (JLE-W01A-2023)

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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Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China.

510(K) Summary K240255

Document Prepared Date: 2024/8/2

A. Applicant:

Zhejiang Jianrui Technology Company Limited. Address: Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. Contact Person: Zhihong Lyu Tel: +86-15967906572

Submission Correspondent: Primary contact: Mr. Jarvis Wu Title: Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: jiawei.wu@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: Electric Wheelchair (JLE-W01A-2023) Common Name: Powered wheelchair Model: JLE-W01A-2023

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

C. Predicate device:

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Zhejiang Jianrui Technology Company Limited. Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China. 510Knumber: K220747 Device Name: Power Wheelchair

Model: N5515B Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

D. Indications for use of the device:

Electric Wheelchair (JLE-W01A-2023) 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 device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, seatbelt, pedal, battery box, charger and anti-tip wheels.

F. Non-Clinical Test Conclusion

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 > 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
ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall >

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Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China.

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
ISO 7176-11:2012 Wheelchairs Part 11: Test dummies. ア
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 devices Requirements 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 7176-25:2022 Wheelchairs Part 25: Lead-acid batteries and chargers for powered wheelchairs >
Requirements and test methods >
IEC 62133-2 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

G. Clinical Test Conclusion

No clinical study is included in this submission.

H. Comparison with predicate Device

Table 1 General Comparison

Elements ofComparison	Subject Device	Predicate Device (K220747)	Remark
Manufacturer	Zhejiang Jianrui TechnologyCompany Limited.	Zhejiang InnuovoRehabilitation Devices Co.,Ltd	-
Common or Usualname	Power Wheelchair	Power Wheelchair	Same
Model(s)	JLE-W01A-2023	N5515B	--
Indications for use	Electric Wheelchair (JLE-W01A-2023) is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to providemobility to a disabled or elderlyperson limited to a seated position.	It is a motor driven, indoor andoutdoor transportation vehiclewith the intended use to providemobility to a disabled or elderlyperson limited to a seatedposition.	S.E.
Use condition	indoor and outdoor use	indoor and outdoor use	S.E
Number of wheels	4, including two front wheels andtwo rear Wheels	4, including two front wheelsand two rear Wheels	S.E
Function of wheels	Front wheels: driven wheelssuitable for rotation, acceleration,retrograde.Rear wheels: driving wheels tocontrol the speed and direction	Front wheels: driven wheelssuitable for rotation,acceleration, retrograde.Rear wheels: driving wheels tocontrol the speed and direction	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	Automatic electromagneticbrake system	Automatic electromagneticbrake system	S.E
Braking distance	1.2m	1.5 m	Analysis
Maximum safeoperational inclinedegree	6°	9°	Analysis
Armrest	PVC	PU	Analysis
Battery charger	Off-board chargerInput: 100-240VAC, 50/60Hz, 2A;Output: 29.4V, 2A	Off-board chargerInput: 100-240V, 50/60Hz, 1.5A,Output: 24 Vdc, 2A;	Analysis
Main frame material	Carbon fiber material	Carbon fiber material	S.E
Back cushion	Synthetic fiber polyester	Polyester fabric	Analysis
Seat cushion	Synthetic fiber polyester	rubber patch cloth and Oxfordfabric	Analysis
Overall Dimension(lengthwidthheight)	1020700890mm	940610960mm	Analysis
Folded Dimension(lengthwidthheight)	700740520mm	720310610mm	Analysis
Front wheel size/type	8" x 2"/PU Solid tire	7" x 1.75"/PU Solid tire	Analysis
Rear wheel size/type	10"x 2"/ PU Pneumatic tire	8.5"x 2"/ PU Solid tire	Analysis
Max speed forward	Up to 6 km/h (1.6 m/s), adjustable	Up to 6 km/h (1.6 m/s),adjustable	S.E
Max Speed backward	Less than 3 km/h (0.5 m/s)	Less than 3 km/h (0.5 m/s)	S.E
Max loading weight	100kg	136kg	Analysis
Battery	Li-ion battery pack; rechargeable, 24 VDC 15Ah	Li-ion battery pack; rechargeable, 24 VDC 12Ah	S.E
Maximum distance of travel on the fully charged battery	27.5 km	15 km	Analysis
Motor	Brushless DC motor; 24VDC; 150W; 2pcs	Brushless DC motor; 24VDC; 250W; 2pcs	Analysis
Electronic controller	Brushless motor controller	Brushless dual-drive rocker controller	S.E
Turning Radius	913mm	900 mm	Analysis
Maximum obstacle climbing	35mm	40 mm	S.E

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Zhejiang Jianrui Technology Company Limited. Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China.

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Zhejiang Jianrui Technology Company Limited. Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China.

Difference analysis:

The design and technological characteristics of the Electric Wheelchair (JLE-W01A-2023) is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Armrest, Seat & Back cushion material, Braking distance, Battery charger, Overall Dimension, Folded Dimension, Wheel size/type, Max loading weight, Maximum distance of travel on the fully charged battery, Motor output and Turning Radius. All of the parameter with difference have been tested according to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious effect on safety and effectiveness due to the minor differences do not influence the intended use of the device. Therefore, the proposed Wheelchair is substantially equivalent (SE) to The Power Wheelchair (K220747).

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.

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements.	All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	S.E.
EMC	ISO7176-21 & IEC 60601-1-2	ISO7176-21 & IEC 60601-1-2	S.E.
Performance	ISO7176 seriesIEC 62133-2	ISO7176 series	S.E.
Label and labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.

Table 2 Safety comparison

Table 3 Safety comparison

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Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China.

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Room 3 to 5 from the north of Building 7, No. 28 Jinshan West Road, Yongkang Economic Development Zone, Jinhua City, Zhejiang Province, China.

I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electric Wheelchair (JLE-W01A-2023), is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220747.

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 design	The Static stability has been determinedafter the testing according to the ISO7176-1, and test results meet its design	S.E.
	specification.	specification.
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,	All test results meet the requirementsin Clause 7, 8, 9, 10, 11, 12, 13, 14,	S.E.
	15, 17 of ISO 7176-14.	15, 17 of ISO 7176-14.
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 7176-16.	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.
ISO 7176-25	The Lead-acid batteries and chargersresults meet the requirements of ISO7176-25.	The Lead-acid batteries and chargersresults meet the requirements of ISO7176-25.	S.E.