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, model: YFWB-63, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped 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 and charger.

The device is powered by Li-ion Battery pack with 25 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.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the "Electric Wheelchair (YFWB-63)" detail a non-clinical study to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria for an AI/Software as a Medical Device (SaMD).

Therefore, I cannot provide information on acceptance criteria and study details related to AI/SaMD, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details. This document focuses on the mechanical and electrical safety and performance of a physical device (electric wheelchair) as per relevant ISO standards.

However, I can extract the acceptance criteria and reported device performance from the provided document as they pertain to the Electric Wheelchair (YFWB-63) and its comparison to the predicate device.

Acceptance Criteria and Reported Device Performance for Electric Wheelchair (YFWB-63)

The study conducted was a non-clinical test to verify that the proposed device met design specifications and was substantially equivalent (SE) to the predicate device (K220747). The acceptance criteria were primarily based on compliance with various ISO 7176 series standards related to wheelchairs and ISO 10993 series for biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Item / Test (Acceptance Criteria)	Reported Device Performance and Compliance
Biocompatibility	All user directly contacting materials are compliant with ISO10993-5 (In Vitro Cytotoxicity), ISO10993-10 (Irritation and Skin Sensitization), and ISO 10993-23 (Irritation) requirements.
Electromagnetic Compatibility (EMC)	Conforms to ISO7176-21 (EMC of electrically powered wheelchairs) and IEC 60601-1-2.
Safety and Performance (ISO 7176 Series)
ISO 7176-1: Static Stability	Static stability determined, test results meet design specification.
ISO 7176-2: Dynamic Stability of Powered Wheelchairs	Dynamic stability determined, test results meet design specification.
ISO 7176-3: Effectiveness of Brakes	Effectiveness of brakes determined, test results meet design specification.
ISO 7176-4: Energy Consumption & Theoretical Distance Range	Theoretical distance range determined, test results meet design specification.
ISO 7176-5: Overall Dimensions, Mass and Manoeuvring Space	Dimensions and mass determined.
ISO 7176-6: Maximum Speed, Acceleration and Deceleration	Dimensions and mass determined (likely referring to parameters defined for these tests). Max speed forward: 6.3 ± 0.5km/h. Max speed backward: Less than 3.8 km/h.
ISO 7176-7: Measurement of Seating and Wheel Dimensions	Seating and wheel dimensions determined. Front wheel size/type: 8" x 2.2"/ TU75+TPU Solid tire. Rear wheel size/type: 10"x 2"/ PU Solid tire.
ISO 7176-8: Static, Impact and Fatigue Strengths	All test results meet the requirements in Clause 4 of ISO 7176-8.
ISO 7176-9: Climatic Tests	Device continued 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: Obstacle-Climbing Ability	Obstacle-climbing ability determined. Maximum obstacle climbing: 15 mm.
ISO 7176-11: Test Dummies	Test dummies used in the ISO 7176 series testing meet the requirements of ISO 7176-11.
ISO 7176-13: Coefficient of Friction of Test Surfaces	Coefficient of friction of test surfaces determined.
ISO 7176-14: Power and Control Systems	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: Information Disclosure, Documentation and Labeling	Information disclosure, documentation, and labeling of the device meet the requirements of ISO 7176-15.
ISO 16840-10 (formerly ISO 7176-16): Resistance to Ignition	Performance of resistance to ignition meets the requirements of ISO 16840-10.
ISO 7176-19: Wheelchairs for Use as Seats in Motor Vehicles	(Standard listed, compliance implied by "Non-Clinical Test Conclusion").
ISO 7176-25: Lead-acid Batteries and Chargers	Performance of batteries and charger meet the requirements of ISO 7176-25.
General Performance Parameters
Braking distance	≤1.5 m
Maximum safe operational incline degree	6°
Max loading weight	100 kg
Maximum distance of travel on fully charged battery	25 km
Turning radius	$1000 \pm 20$ mm
Battery type	Li-ion battery pack; rechargeable, 24 VDC 25Ah.
Motor type	Brushless DC motor; 24VDC; 250W; 2pcs.
Controller type	Brushless dual-drive rocker controller.

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for software evaluation. Instead, it refers to physical testing of the device itself. The tests were conducted according to various ISO standards. The data provenance would be the test reports generated from these physical tests of the Electric Wheelchair (YFWB-63) device. No information on country of origin of the data or retrospective/prospective status as it pertains to a dataset is applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the non-clinical testing of a physical medical device like an electric wheelchair. "Ground truth" in this context refers to established engineering standards (like ISO 7176) and directly measured physical performance, not expert consensus on medical images or patient outcomes. The testing would be performed by qualified engineers at a testing facility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with human-in-the-loop medical image review or similar subjective evaluations requiring multiple experts.

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 is not an AI/SaMD device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD device. No algorithm is being evaluated in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the performance requirements and test methods defined by the referenced International Standards (ISO 7176 series, ISO 10993 series, etc.). The device's physical performance (e.g., speed, stability, braking distance, biocompatibility) was measured and compared against these objective, established standards.

8. The sample size for the training set
Not applicable. This is not an AI/SaMD device. There is no training set for a machine learning model.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD device.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

June 28, 2024

IF Health (Xiamen) Intelligent Technology Co.,Ltd % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, Shanghai 200122 China

Re: K241154

Trade/Device Name: Electric Wheelchair (YFWB-63) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 24, 2024 Received: June 24, 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.

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

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K241154

Device Name Electric Wheelchair (YFWB-63)

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)

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IF Health (Xiamen) Intelligent Technology Co.,Ltd Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang 'an) Industrial Zone, Xiamen, Fujian, China.

510(k) Summary K241154

A. Applicant:

IF Health (Xiamen) Intelligent Technology Co.,Ltd Address: Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang'an) Industrial Zone, Xiamen, Fujian, China. Contact Person: Xiang Gao Tel: +86- 13600895372

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 Common Name: Powered wheelchair Model: YFWB-63

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

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IF Health (Xiamen) Intelligent Technology Co.,Ltd Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang'an) Industrial Zone, Xiamen, Fujian, China.

C. Predicate device:

510Knumber: K220747 Classification Name: Powered wheelchair Regulation Number: 890.3860 Device Name: Power Wheelchair Model: N5515B 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:

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

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:

ハ 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

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IF Health (Xiamen) Intelligent Technology Co.,Ltd

Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang'an) Industrial Zone, Xiamen, Fujian, China.

wheelchairs and wheelchairs for determination of theoretical distance range

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
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 A 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 7176-19:2022 Wheelchairs Part 19: Wheelchairs for use as seats in motor vehicles
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

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	IF Health (Xiamen) IntelligentTechnology Co.,Ltd	Zhejiang InnuovoRehabilitation Devices Co.,Ltd	-
Common or Usualname	Power Wheelchair	Power Wheelchair	Same
Model(s)	YFWB-63	N5515B	--
Indications for use	It 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 elderlypersonlimited to a seatedposition.	S.E.
Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang'an) IndustrialZone, Xiamen, Fujian, China.
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	≤1.5 m	≤1.5 m	S.E
Maximum safeoperational inclinedegree	6 °	9 °	Analysis
Armrest	ABS	PU	Analysis
Battery charger	Off-board chargerInput: 100-240V, 50/60Hz, 3.5A,Output: 24 Vdc, 8A;	Off-board chargerInput: 100-240V, 50/60Hz, 1.5A,Output: 24 Vdc, 2A;	Analysis
Main frame material	Steel	Carbon fiber material	Analysis
Back cushion	PVC	Polyester fabric	Analysis
Seat cushion	PVC	rubber patch cloth and Oxfordfabric	Analysis
Overall Dimension(lengthwidthheight)	1050±20650±201150±50mm	940610960mm	S.E
Folded Dimension(lengthwidthheight)	1055614598 mm	720310610mm	S.E
Front wheel size/type	8" x 2.2"/ TU75+TPU Solid tire	7" x 1.75"/PU Solid tire	Analysis
Rear wheel size/type	10"x 2"/ PU Solid tire	8.5"x 2"/PU Solid tire	Analysis
Max speed forward	6.3 ± 0.5km/h	Up to 6 km/h (1.6m/s),adjustable	S.E
Max Speed backward	Less than 3.8 km/h	Less than 3 km/h (0.8m/s)	S.E
Max loading weight	100 kg	136 kg	Analysis
Battery	Li-ion battery pack; rechargeable, 24 VDC 25Ah	Li-ion battery pack; rechargeable, 24 VDC 12Ah	Analysis
Maximum distance oftravel on the fullycharged battery	25 km	15 km	Analysis
Motor	Brushless DC motor; 24VDC; 250W; 2pcs	Brushless DC motor; 24VDC; 250W; 2pcs	S.E
Electronic controller	Brushless dual-drive rocker controller	Brushless dual-drive rocker controller	S.E
Turning radius	$1000 \pm 20$ mm	900 mm	Analysis
Maximum obstacleclimbing	15	40 mm	Analysis

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IF Health (Xiamen) Intelligent Technology Co.,Ltd Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang'an) Industrial

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IF Health (Xiamen) Intelligent Technology Co.,Ltd Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang 'an) Industrial Zone, Xiamen, Fujian, China.

Difference analysis:

The design and technological characteristics of the Electric Wheelchair is similar to the predicates chosen. There are minor differences between the devices including Maximum safe operational incline degree, Main frame material, Armrest, Seat & Back cushion, Battery charger, Front &Rear wheel size/type, Max loading weight, Battery,Maximum distance of travel on the fully charged battery, Turning Radius and Maximum obstacle climbing. All of the parameter with difference have been tested according to ISO 7176 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.

	Table 2 Safety comparison

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5, ISO10993-10 andISO 10993-23 requirements.	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.	S.E.
EMC	ISO7176-21 & IEC 60601-1-2	ISO7176-21	S.E.
Performance	ISO7176 series	ISO7176 series	S.E.
Label and labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.

Table 3 Safety comparison

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IF Health (Xiamen) Intelligent Technology Co.,Ltd

Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang'an) Industrial Zone, Xiamen, Fujian, China.

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IF Health (Xiamen) Intelligent Technology Co.,Ltd Zone A, 4th Floor, No.3 Building, No.66, xiangyue Rd, Torch High-tech Zone(Xiang'an) Industrial Zone, Xiamen, Fujian, China.

I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(k) submission, Electric Wheelchair, model:YFWB-63, 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 determined after the testing according to the ISO 7176-1, and test results meet its design specification.	The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification.	S.E.
ISO7176-2	The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification.	The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification.	S.E.
ISO7176-3	The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification.	The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification.	S.E.
ISO7176-4	The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification.	The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification.	S.E.
ISO7176-5	The dimensions, mass has been determined after the testing according to the ISO 7176-5	The dimensions, mass has been determined after the testing according to the ISO 7176-5	S.E.
ISO7176-6	The dimensions, mass has been determined after the testing according to the ISO 7176-6	The dimensions, mass has been determined after the testing according to the ISO 7176-6	S.E.
ISO7176-7	The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7	The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7	S.E.
ISO7176-8	All test results meet the requirements in Clause 4 of ISO 7176-8	All test results meet the requirements in Clause 4 of ISO 7176-8	S.E.
ISO7176-9	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	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	S.E.
ISO7176-10	The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10	The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10	S.E.
ISO7176-11	The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11	The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11	S.E.
ISO7176-13	The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved	The coefficient of friction of test surfaces has been determined, which could be used 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 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.
ISO7176-25	The performance of batteries and chargerof device meet the Requirements of ISO7176-25	The performance of batteries and chargerof device meet the Requirements of ISO7176-25	S.E.