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, models: Panda 10 and Panda 12, 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, pedal, battery box and charger.

The device is powered by Li-ion Battery pack with 9.7 Km range, which can be recharged by an off- board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The 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

This document is a 510(k) premarket notification for an electric wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for AI performance. Therefore, the information requested in the prompt regarding AI-related studies and acceptance criteria is not present in this document.

Specifically, the document includes:

Non-Clinical Test Conclusion (Section F): This section lists various ISO standards that the device complies with, such as ISO 10993 (biocompatibility) and ISO 7176 (wheelchair-specific performance like stability, braking, speed, etc.). These are engineering and safety standards, not performance criteria for an AI-powered system.
Clinical Test Conclusion (Section G): Explicitly states, "No clinical study is included in this submission." This confirms the absence of human subject trials or performance evaluations that would typically feature AI-related acceptance criteria.
Comparison with Predicate Device (Section H): This table compares the subject device and the predicate device across various physical and functional parameters, demonstrating similarity. There is no mention of AI functionality in either device.
Table 2 and Table 3 Safety Comparison: These tables reiterate compliance with various ISO standards for safety and performance, again not related to AI.

Given the content, I cannot provide the requested information about AI acceptance criteria and study details because the device described is an electric wheelchair, and the submission focuses on its mechanical, electrical, and safety performance in comparison to a predicate device, not on AI-driven capabilities.

Summary

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August 9, 2024

Suzhou Ideal Medical Co., Ltd. % Jarvis Wu Senior Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave Shanghai, Shanghai 200122 China

Re: K240079

Trade/Device Name: Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: July 19, 2024 Received: July 19, 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 (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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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.

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

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Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

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

Submission Number (if known)

K240079

Device Name

Electric Wheelchair (Panda 10); Electric Wheelchair (Panda 12)

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 K240079

Preparation date: July 19, 2024

A. Applicant:

SUZHOU IDEAL MEDICAL CO., LTD. Address: No.88 Huachi Street, Suzhou Industrial Park, Suzhou (215000), Jiangsu, China. Contact Person: Hu Qi Tel: +86-13912803601

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 Panda 10, Panda 12 Common Name: Powered wheelchair Regulatory Information Classification Name: Powered wheelchair Classification: Class II. Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine

C. Predicate device:

510K number: K220747 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:

This Electric Wheelchair, models: Panda 10 and Panda 12, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and

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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, pedal, battery box and charger.

Non-Clinical Test Conclusion F.

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For A In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part 10: Tests For > Irritation And Skin Sensitization
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 A 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

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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 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for ア electromagnetic compatibility of electrically powered wheelchairs and wheelchairs, and battery chargers
ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs >
ISO 16840-10:2021 Wheelchairs Part 16: Resistance to ignition of postural support devices. >

Clinical Test Conclusion G.

No clinical study is included in this submission.

Comparison with predicate Device H.

Elements ofComparison	Subject Device	Predicate Device (K220747)	Remark
Manufacturer	SUZHOU IDEALMEDICAL CO.,LTD.	Zhejiang InnuovoRehabilitation Devices Co.,Ltd	-
Common or Usualname	Power Wheelchair	Power Wheelchair	Same
Model(s)	Panda 10 & Panda 12	N5515B	--
Indications for use	It is a motor driven,indoor and outdoortransportation vehiclewith the intended useto provide mobility toa disabled or elderlyperson limited to aseated position.	It is a motor driven, indoor andoutdoor transportation vehicle withthe intended use to provide mobilityto a disabled or elderly person limitedto a seated position.	S.E.
Use condition	indoor and outdoor use	indoor and outdoor use	S.E
Number of wheels	4,including two frontwheels and two rearWheels	4,including two front wheels andtwo rear Wheels	S.E
Function of wheels	Front wheels: drivenwheels suitable forrotation, acceleration,retrograde.Rear wheels: drivingwheels to control thespeed and direction	Front wheels: driven wheels suitablefor rotation, acceleration, retrograde.Rear wheels: driving wheels tocontrol the speed and direction	S.E
Movement control	By Joystick control	By Joystick control	S.E
method
Driving system	Directdrive onthe rearwheels	Direct drive on the rearwheels	S.E
Brake system	Automaticelectromagnetic brake system	Automatic electromagneticbrake system	S.E
Braking distance	≤ 1.5 m	≤ 1.5 m	S.E
Maximum safeoperational inclinedegree	10°	9 °	S.E
Armrest	Mesh Fabric(Polyester& Spandex)	PU	Analysis
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;	Analysis
Main frame material	Aluminum Alloy	Carbon fiber material	Analysis
Back cushion	Mesh Fabric(Polyester& Spandex)	Polyester fabric	Analysis
Seat cushion	Mesh Fabric(Polyester& Spandex)	rubber patch cloth and Oxford fabric	Analysis
Overall Dimension(lengthwidthheight)	Panda10model:1000630880mmPanda 12 model:1065630930mm	940610960mm	Analysis
Folded Dimension(lengthwidthheight)	Panda 10model:730630410mmPanda 10model:770630410mm	720310610mm	Analysis
Front wheel size/type	Panda 10 model: 7" x2"/PU Solid tirePanda 12 model: 8" x2"/PU Solid tire	7" x 1.75"/PU Solid tire	Analysis
Rear wheel size/type	Panda 10 model:10" x 2.4"/PUSolid tirePanda 12 model: 12"x 2.3"/ RubberPneumatic tire	8.5"x 2"/ PU Solid tire	Analysis
Max speed forward	Up to adjustable 6.8km/h (1.9 m/s),	Up to 6 adjustable km/h (1.6 m/s)	S.E
Max Speed backward	Less than 3.2 km/h (0.9m/s)	Less than 3 km/h (0.5 m/s)	S.E
Max loading weight	120Kg	136kg	S.E
Battery	Lithium 24V10Ah	Li-ion battery pack;rechargeable, 24 VDC 12Ah	S.E
Maximum distance oftravel on the fullycharged battery	9.7km	15 km	Analysis
Motor	Brushless DC motor;24VDC;	Brushless DC motor; 24VDC;	S.E
Motor	220W; 2pcs	250W; 2pcs	S.E
Electronic controller	Brushless controller	Brushless dual-drive rockercontroller	S.E
Turning Radius	1070 mm	900 mm	S.E
Maximum obstacleclimbing	20 mm	40 mm	Analysis

Table 1 General Comparison

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I. 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 Armrest, Seat & Back cushion material, Main frame material, Overall Dimension, Folded Dimension, Wheel size/type, Maximum distance of travel on the fully charged battery 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

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(K220747).

Table 2 Safety comparison

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5, ISO10993-10 andISO10993-23 requirements.(Having long-term skin contactof greater than 30 days)	All user directlycontacting materials arecompliance withISO10993-5 andISO10993-10requirements.	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 FDARegulatory	S.E.

Table 3 Safety comparison

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J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, Electric Wheelchair, Models: Panda 10 & Panda 12, 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 beendetermined after the testingaccording to the ISO 7176-1, andtest results meet its designspecification.	The Static stability has beendetermined after the testingaccording to the ISO 7176-1, andtest results meet its designspecification.	S.E.
ISO7176-2	The dynamic stability has beendetermined after the testingaccording to the ISO 7176-2, andtest results meet its designspecification.	The dynamic stability has beendetermined after the testingaccording to the ISO 7176-2, andtest results meet its designspecification.	S.E.
ISO7176-3	The effectiveness of brakes hasbeen determined after the testingaccording to the ISO 7176-3, andtest results meet its designspecification.	The effectiveness of brakes hasbeen determined after the testingaccording to the ISO 7176-3, andtest results meet its designspecification.	S.E.
ISO7176-4	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, andtest results meetits design specification.	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, andtest results meetits design specification.	S.E.
ISO7176-5	The dimensions, mass has beendetermined after the testingaccording to the ISO 7176-5.	The dimensions, mass has beendetermined after the testingaccording to the ISO 7176-5.	S.E.
ISO7176-6	The dimensions, mass has beendetermined after the testingaccording to the ISO 7176-6.	The dimensions, mass has beendetermined after the testingaccording to the ISO 7176-6.	S.E.
ISO7176-7	The seating and wheel dimensionshas been determined after thetestingaccording to the ISO 7176-7.	The seating and wheeldimensions has been determinedafter 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 ofISO7176-8.	S.E.
ISO7176-9	The test results shown that thedevice under tests could continueto function according tomanufacturer's specification afterbeing subjected to each of thetests specified in Clause 8of ISO 7176-9.	The test results shown that thedevice under tests couldcontinue to function accordingto manufacturer's specificationafter being subjected to each ofthe tests specified in Clause 8of ISO 7176-9.	S.E.
ISO7176-10	The obstacle-climbing ability ofdevice has been determinedafter thetesting according to the ISO 7176-10.	The obstacle-climbing abilityof device has been determinedafter thetesting according to the ISO 7176-10.	S.E.
ISO7176-11	The test dummies used in thetesting of ISO 7176 series are meettherequirements of ISO 7176-11.	The test dummies used in thetesting of ISO 7176 series aremeet therequirements of ISO 7176-11.	S.E.
ISO7176-13	The coefficient of friction of testsurfaces has been determined, whichcould be used in other 7176 seriestests involved.	The coefficient of friction of testsurfaces has been determined,which could be used in other 7176series tests involved.	S.E.
ISO7176-14	All test results meet therequirements in Clause 7, 8, 9,10, 11, 12, 13, 14,15, 17 of ISO 7176-14.	All test results meet therequirements in 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,documentation and labelling ofdevice meet therequirements of ISO 7176-15.	The test results shown thatinformation disclosure,documentation and labelling ofdevice meet therequirements of ISO 7176-15.	S.E.
ISO 16840-10	The performance ofresistance to ignition meetthe requirements ofISO 16840-10	The performance ofresistance to ignition meetthe requirements ofISO 7176-16.	S.E.
ISO 7176-21	The EMC performance resultsmeet the requirements of ISO7176-21.	The EMC performance resultsmeet the requirements of ISO7176-21.	S.E.
ISO 7176-25	The performance of batteries andcharger of device meet theRequirements in Clause 5 and 6 ofISO 7176-25.	The performance of batteries andcharger of device meet theRequirements in Clause 5 and 6 ofISO 7176-25.	S.E.