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

Device Description

The Mobility Scooter, Models: W3331F, has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, electromagnetic brake, 2 rechargeable Lead-acid Batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

AI/ML Overview

The provided document is a 510(k) summary for a Mobility Scooter, Model W3331F, and focuses on demonstrating substantial equivalence to a predicate device (K220206). It primarily relies on non-clinical performance testing against established ISO standards rather than clinical studies or AI performance metrics.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on compliance with specifically cited ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The "reported device performance" is a statement of compliance with these standards.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Biocompatibility	ISO 10993-5:2009 (Cytotoxicity) & ISO 10993-10:2010 (Irritation & Skin Sensitization) for all user-contacting materials.	"All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements."
Electromagnetic Compatibility (EMC)	ISO 7176-21:2009 (Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers)	"The EMC performance results meet the requirements of ISO 7176-21."
Overall Performance & Safety (various)	ISO 7176-1:2014: Determination of static stability ISO 7176-2:2017: Determination of dynamic stability of Powered Wheelchairs ISO 7176-3:2012: Determination of effectiveness of brakes ISO 7176-4:2008: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range ISO 7176-5:2008: Determination of overall dimensions, mass and manoeuvring space ISO 7176-6:2018: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs ISO 7176-7: Measurement of seating and wheel dimensions ISO 7176-8:2014: Requirements and test methods for static, impact and fatigue strengths ISO 7176-9:2009: Climatic tests for Powered Wheelchairs ISO 7176-10:2008: Determination of obstacle-climbing ability of electrically powered wheelchairs ISO 7176-11:2012: Test dummies ISO 7176-13:1989: Determination of coefficient of friction of test surfaces ISO 7176-14:2008: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods ISO 7176-15:1996: Requirements for information disclosure, documentation and labeling ISO 7176-16:2012: Resistance to ignition of postural support devices ISO 7176-25:2013: Batteries and chargers for powered wheelchairs	For each listed ISO 7176 standard, the reported performance states that the testing was conducted according to the standard and that "test results meet its design specification" or "All test results meet the requirements" or similar language indicating full compliance. For example, for ISO 7176-1: "The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification."
Labeling	Conforms to FDA Regulatory	"Conforms to FDA Regulatory"

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

Sample Size for Test Set: Not specified. The document describes non-clinical testing against ISO standards for a single device model (Mobility Scooter, Model W3331F). It does not involve a "test set" in the context of a dataset for an AI algorithm. The testing is on the physical device itself.
Data Provenance: Not applicable in the context of patient data. The "data" are the results of physical and electrical engineering tests performed on the device. No country of origin for the data is explicitly mentioned, but the manufacturer is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China, suggesting the testing likely occurred there. The tests are non-clinical, so the "retrospective or prospective" distinction does not apply.

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

This section is not applicable as the document describes physical device testing against engineering standards, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The device is a physical mobility scooter, not an AI diagnostic or assistance tool that would typically undergo such a study.

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

This section is not applicable. The device is a physical mobility scooter and does not involve an AI algorithm with standalone performance to be evaluated.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The test results demonstrate that the device meets the specifications outlined in these standards.

8. The Sample Size for the Training Set

This section is not applicable. The document does not describe an AI algorithm that requires a training set. The device is a physical product.

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

This section is not applicable as there is no AI algorithm or training set for this device.

Summary

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Image /page/0/Picture/2 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

October 17, 2022

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai 200122, China Shanghai, Shanghai 200122 China

Re: K222495

Trade/Device Name: Mobility Scooter, Model: W3331F Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 18, 2022 Received: August 18, 2022

Dear Jarvis Wu:

We have reviewed vour 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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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, PhD Acting 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 Ouality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K222495

Device Name Mobility Scooter, Model: W3331F

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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510(K) Summary

Document Prepared Date: 2022/8/5

A. Applicant:

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China Contact Person: Leo Zheng Tel: + 86 18358936043

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com

B. Device:

510Knumber: K222495 Trade Name: Mobility Scooter, Model: W3331F Common Name: Scooter Regulatory Information Classification Name: Motorized three-wheeled vehicle Classification: Class II. Product code: INI Regulation Number: 890.3800 Review Panel: Physical Medicine

C. Predicate device:

510Knumber: K220206 Device Name: Mobility Scooter Model: W3468A Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

D. Indications for use of the device:

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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:

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 A 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 scooters 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 A of friction of test surfaces
ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, documentation > and labeling
ISO 7176-16:2012 Wheelchairs - Part 16: Resistance to ignition of postural support devices.

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ISO 7176-21:2009 Wheelchairs Part 21: Requirements and test methods for electromagnetic > compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-25:2013 Wheelchairs Part 25: Batteries and chargers for powered wheelchairs ♪

G. Clinical Test Conclusion

No clinical study is included in this submission.

H. Comparison with predicate Device

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

Elements ofComparison	Predicate Device (K220206)	Subject Device (K222495)	Remark
Manufacturer	Zhejiang Innuovo RehabilitationDevices Co.,Ltd	Zhejiang Innuovo RehabilitationDevices Co.,Ltd	Same
Common orUsual name	Scooter	Scooter	Same
Model(s)	W3468A	W3331F	ーー
Indicationsfor use	It is a motor driven, indoor andoutdoor transportation vehicle with theintended use to provide mobility to adisabled or elderly person limited to aseated position.	It is a motor driven, indoor andoutdoor transportation vehicle with theintended use to provide mobility to adisabled or elderly person limited to aseated position.	S.E.
Overalldimension	1075 mm x 500 mm x 920 mm	940 mm x 500 mm x 840 mm	Similar
FrameMaterial	Steel	Steel	S.E.
Frame style	Foldable seat, removable battery pack,disassemble for transport	Foldable seat, removable battery pack,disassemble for transport	S.E.
Front wheelsize	200 x 50 mm	190 x 55 mm	Analysis
Front WheelsQuantity	2	1	Analysis
Rear wheelsize	200 x 50 mm	190 x 55 mm	Analysis
Rear WheelsQuantity	2	2	S.E.
Groundclearance	100mm(3.9")	45 mm	Analysis
MaxLoading( onlevel ground)	136kg	120kg	Analysis
Turn Radius	1350mm(53")	1200mm	Analysis
Motor output	250W	24 V 180W	Analysis
Drive System	Rear Wheel Drive	Rear Wheel Drive	S.E.
Brakes	Electromagnetic brake	Electromagnetic brake	S.E.
Battery	Lead Acid 12V x 2 (12Ah or 20Ah)	Lead-acid 12V12Ah*2	S.E.
Charger	24V/2A	24V/2A	S.E.
Max Speed	6.4km/h	6 km/h	S.E.
Slope GradeAbility	9 degree	9 degree	S.E.
TravelDistance	14km / 9 Miles (12Ah)	15 km/9.32 Miles	S.E.
Arm Rests(Distancebetweenarmrests)	44 cm	44-56 cm	Analysis
Controller	PG45A	45 A	Similar
Time tobrake	0.7-1s	< 1 s	S.E.
BrakeDistance-Normaloperation(Horizontal-Forwa rd-Max speed)	≤1.5m	≤1.5m	S.E.
Batteryweight	Battery Pack (12Ah) – 9kg (20lb)Battery Pack (20Ah) - 14kg (31lb)	8.8kg	Analysis
Base weight(notincludingbattery)	45kg	38kg	Analysis
Operatingsurface &environment	Indoor use and restricted outdoor useon pavements or paved footpaths only.	Indoor use and restricted outdoor useon pavements or paved footpaths only.	S.E.
Remotecontrol	None	None	S.E.

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I. Difference analysis

The design and technological characteristics of the Electric Scooter is similar to the predicates chosen. There are minor differences between the devices including Front & Rear wheel size, Front wheels Quantity, Ground Clearance, Max Loading, Turn Radius, Motor output, Arm Rests (Distance between armrests), Battery weight, and Base weight (not including battery). All of the parameter with difference have been tested according to ISO7176 series standards and the test records support its

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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 Scooter is substantially equivalent (SE) to The Scooter (K220206).

Item	Proposed Device	Predicate Devices	Results
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.	S.E.
	EMC	ISO7176-21	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 2 Safety comparison

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, the Mobility scooter, model W3331F , is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K220206.

Regulation Number and Section

§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(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 7176-5,	The dimensions, mass has been determined after the testing according to the ISO 7176-5,	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.
	The test results shown that the device	The test results shown that the device	S.E.
ISO7176-9	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	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
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 testsurfaces hasbeen determined, which could be usedin other 7176 series tests involved	The coefficient of friction of testsurfaces hasbeen determined, which could be usedin other 7176 series 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 the requirements ofISO 7176-15	The test results shown thatinformation disclosure,documentation and labelling ofdevice meet the requirements of ISO7176-15	S.E.
ISO7176-16	The performance of resistance toignition meet the requirements ofISO 7176-16	The performance of resistance toignition meet the requirements ofISO 7176-16	S.E.
ISO 7176-21	The EMC performance results meetthe requirements of ISO 7176-21	The EMC performance results meet therequirements of ISO 7176-21	S.E.
ISO7176-25	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 of ISO7176-25	S.E.