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 W3468, has a base with Steal frame, two front wheels, a seat, a tiller console, electromagnetic brake, front light, USB charging port (Transfer power only), 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 document is a 510(k) Summary for a Mobility Scooter (Model: W3468). It describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device (K182471).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Mobility Scooter (Model: W3468) are based on demonstrating compliance with a series of ISO 7176 standards. The reported device performance indicates that the device met these standards.

Acceptance Criteria (Standard)	Reported Device Performance (Reference to Standard Compliance)
Biocompatibility	All user directly contacting materials are compliant with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization) requirements.
EMC (Electromagnetic Compatibility)	ISO 7176-21: The EMC performance results meet the requirements of ISO 7176-21.
Performance (ISO 7176 Series)	ISO 7176-1 (Static Stability): The static stability has been determined after testing according to ISO 7176-1, and test results meet its design specification. ISO 7176-2 (Dynamic Stability): The dynamic stability has been determined after testing according to ISO 7176-2, and test results meet its design specification. ISO 7176-3 (Effectiveness of Brakes): The effectiveness of brakes has been determined after testing according to ISO 7176-3, and test results meet its design specification. ISO 7176-4 (Energy Consumption/Theoretical Distance Range): The theoretical distance range has been determined after testing according to ISO 7176-4, and test results meet its design specification. ISO 7176-5 (Overall Dimensions, Mass, and Maneuvering Space): The dimensions, mass has been determined after testing according to ISO 7176-5. ISO 7176-6 (Maximum Speed, Acceleration, and Deceleration): The dimensions, mass has been determined after testing according to ISO 7176-5 (Note: This might be a typo in the document repeatedly referencing 7176-5 for two separate sections; it should likely reference 7176-6 for speed, acceleration, and deceleration). ISO 7176-7 (Seating and Wheel Dimensions): The seating and wheel dimensions have been determined after testing according to ISO 7176-7. 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): The test results showed that the device under test 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 (Obstacle-climbing Ability): The obstacle-climbing ability of the device has been determined after testing according to ISO 7176-10. ISO 7176-11 (Test Dummies): The test dummies used in the testing of ISO 7176 series meet the requirements of ISO 7176-11. ISO 7176-13 (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 (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): The test results showed that information disclosure, documentation, and labeling of device meet the requirements of ISO 7176-15. ISO 7176-16 (Resistance to Ignition of Postural Support Devices): The performance of resistance to ignition met the requirements of ISO 7176-16. ISO 7176-25 (Batteries and Chargers): The performance of batteries and charger of device met the requirements in Clause 5 and 6 of ISO 7176-25.
Label and labeling	Conforms to FDA Regulatory.

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

The document does not explicitly state the "sample size used for the test set" in terms of number of devices. Non-clinical tests were conducted on the "proposed device" (Mobility Scooter, Model W3468).

The provenance of the data is from non-clinical testing performed by the manufacturer, Zhejiang Innuovo Rehabilitation Devices Co., Ltd, in China. This is a prospective testing approach conducted specifically for this premarket notification.

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

Not applicable for this type of submission. The "ground truth" for the non-clinical tests is established by the specifications and criteria outlined in the referenced ISO standards. The tests are typically performed by qualified engineers or technicians in a testing facility. The document does not specify the number or qualifications of these individuals, but generally, such testing requires expertise in the relevant engineering and ISO standards.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical tests against ISO standards usually involve objective measurements and comparisons against predefined thresholds, rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a non-clinical 510(k) submission for a physical medical device (mobility scooter) and does not involve AI or human readers for diagnostic interpretation.

6. Standalone (Algorithm Only) Performance Study

No. This is a non-clinical 510(k) submission for a physical medical device (mobility scooter) and does not involve an algorithm.

7. Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on the objective, measurable requirements and specifications defined by the international standards of the ISO 7176 series, ISO 10993 series, and FDA regulations for labeling.

8. Sample Size for the Training Set

Not applicable. This is a non-clinical 510(k) submission for a physical medical device and does not involve AI or machine learning models that require a training set.

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

Not applicable, as there is no training set for this type of device submission.

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 and Human Services logo. To the right of that 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.

March 24, 2022

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

Re: K220207

Trade/Device Name: Mobility Scooter (Model: W3468) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: January 25, 2022 Received: January 25, 2022

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 (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, Heather L. Dean -S Heather Dean, PhD

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

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Indications for Use

510(k) Number (if known) K220207

Device Name Mobility Scooter (Model: W3468)

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: 2022/1/21

Applicant: A.

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd Address: No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejjang.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:

Trade Name: Mobility Scooter Common Name: Scooter Model: W3468

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: K182471 Device Name: Scooter Model: KPL001 Tianjin Kepler Vehicle Industry 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 TestConclusion

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: 2010 Biological Evaluation of Medical Devices Part 10: Tests For Irritation And A Skin Sensitization
ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability >
A 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 A
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, A mass and manoeuvring space
ISO 7176-6: 2018. Wheelchairs Part 6: Determination of maximum speed, acceleration and A 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 A
ISO 7176-10:2008. Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically A powered wheelchairs
ISO 7176-11:2012 Wheelchairs Part 11: Test dummies. A
A ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
A ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
A 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.
A 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

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No clinical study is included in this submission.

Elements ofComparison	Subject Device(s)	Predicate Device (K182471)	Remark
Manufacturer	Zhejiang Innuovo RehabilitationDevices Co.,Ltd	Tianjin Kepler Vehicle Industry Co.Ltd.	--
Common orUsual name	Scooter	Scooter	Same
Model(s)	W3468	KPL001	--
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 510 mm x 930 mm	1030mm/40.6" x 630mm/24.8" x920mm/36.2"	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	225 x 65 mm	190 x 54 mm	Analysis
Front WheelsQuantity	2	2	S.E.
Rear wheelsize	225 x 65 mm	215 x 70 mm	Analysis
Rear WheelsQuantity	2	2	S.E.
Groundclearance	85mm(3.3")	45 mm(1.8")	Analysis
MaxLoading( onlevel ground)	160kg	120 kg/265 lbs approx.	Analysis
Turn Radius	1800mm / 70"	1300 mm(51.2")	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 (22Ah)	Lead-acid 24V/12AH	S.E.
Charger	24V/2A	24V/2A	S.E.
Max Speed	6.4 km/h	6.6 km/h	S.E.
Slope GradeAbility	9 degree	0-12 degree	Analysis
TravelDistance	20km / 14 mile (22Ah)	15 km/9.32 Miles	Analysis
Arm Rests(Distancebetweenarmrests)	45 cm	No available data	N/A
Controller	PG45A	PG45A	S.E.
Time tobrake	0.7-1s	< 1 s	S.E.
BrakeDistance-Normaloperation(Horizontal-Forwa rd-Max speed)	$≤$ 1.5m	1m	S.E.
Batteryweight	14kg (31lb)	10.2 kg/22.5 lbs	Analysis
Base weight(notincludingbattery)	58kg	50 kg/110 lbs	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.
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.

H. Comparison with predicate Device Table 1 General Comparison

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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, Ground clearance, Max Loading(on level ground), Turn Radius, Motor output, Slope Grade Ability, Travel Distance, 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 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

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equivalent (SE) to The Scooter (K182471).

Table 2 Safety comparison

Table 3 Safety comparison

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Zhejiang Innuovo Rehabilitation Devices Co.,Ltd No.196 Industry Road, Hengdian Movie Zone, Dongyang, Zhejiang,China

J. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Mobility scooter, model W3468, is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K182471.

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 beendetermined after the testing accordingto the ISO 7176-1, and test resultsmeet its design specification.	The Static stability has beendetermined after the testing accordingto the ISO 7176-1, and test results meetits design specification.	S.E.
ISO7176-2	The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test resultsmeet its design specification.	The dynamic stability has beendetermined after the testing accordingto the ISO 7176-2, and test results meetits design specification.	S.E.
ISO7176-3	The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test resultsmeet its design specification.	The effectiveness of brakes has beendetermined after the testing accordingto the ISO 7176-3, and test results meetits design specification.	S.E.
ISO7176-4	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification.	The theoretical distance range hasbeen determined after the testingaccording to the ISO 7176-4, and testresults meet its design specification.	S.E.
ISO7176-5	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5,	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5,	S.E.
ISO7176-6	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5,	The dimensions, mass has beendetermined after the testing accordingto the ISO 7176-5,	S.E.
ISO7176-7	The seating and wheel dimensionshas been determined after the testingaccording to theISO 7176-7,	The seating and wheel dimensionshas been determined after the testingaccording to theISO 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.
		S.E.
ISO7176-9	The test results shown that the deviceunder tests could continue tofunction according 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 testingof ISO 7176 series are meet therequirements of ISO 7176-11	The test dummies used in the testingof ISO 7176 series are meet therequirements 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.