lt 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 Solax Electric Scooter (Models: S302121, S302131, S302141, S302151) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a remote for folding/unfolding the device and a Lithium battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. 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.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Solax Electric Scooter." It describes the device, its intended use, a comparison to a predicate device, and a summary of performance and safety tests.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format typically associated with an AI/ML device study. Instead, it lists various ISO and IEC standards that the device was tested against to demonstrate safety and effectiveness. The "reported device performance" is implicitly that the device met the requirements of these standards.

Here's a table based on the provided information, interpreting the standards as acceptance criteria for the respective performance aspects:

Acceptance Criteria (Reference Standard)	Reported Device Performance (Implied)
Mechanical/Physical Performance
ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability	Compliant with static stability requirements.
ISO 7176-2:2001, Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs	Compliant with dynamic stability requirements.
ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes	Compliant with brake effectiveness requirements.
ISO 7176-4, Third edition 2008-10-01, Wheelchairs Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range	Compliant with energy consumption and theoretical distance range determination.
ISO 7176-5, Second edition 2008-06-01, Wheelchairs Part 5: Determination of overall dimensions, mass and manoeuvring space	Compliant with overall dimensions, mass, and manoeuvring space requirements.
ISO 7176-6: 2001, Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs	Compliant with maximum speed, acceleration, and deceleration requirements.
ISO 7176-7, First Edition 1998-05-15, Wheelchairs Part 7: Measurement of seating and wheel dimensions	Compliant with seating and wheel dimensions requirements.
ISO 7176-8:2014, Wheelchairs Part 8: Requirements and test methods for static, impact and fatigue strengths	Compliant with static, impact, and fatigue strengths requirements.
ISO 7176-10:2008, Wheelchairs Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs	Compliant with obstacle-climbing ability requirements.
ISO 7176-11, Second edition 2012-12-01, Wheelchairs Part 11: Test dummies	Compliant with test dummy specifications (implies proper testing methodology).
ISO 7176-13, First edition 1989-08-01, Wheelchairs Part 13: Determination of friction of test surfaces	Compliant with friction of test surfaces (implies proper testing methodology).
Electrical/Control Systems Performance
ISO 7176-14:2008, Wheelchairs Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods	Compliant with power and control systems requirements.
ISO 7176-21 Second edition 2009-04-01 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers	Compliant with electromagnetic compatibility requirements.
Environmental Performance
ISO 7176-9:2009, Wheelchairs Part 9: Climatic tests for Powered Wheelchairs	Compliant with climatic test requirements.
Biocompatibility
ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity	All user-contacting materials compliant with In Vitro cytotoxicity requirements.
ISO 10993-10: 2009, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity	All user-contacting materials compliant with irritation and delayed-type hypersensitivity requirements.
Software/Usability
IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.	Compliant with medical device software life-cycle processes.
IEC 60601-1-6 Medical electrical equipment-Part1-6: General requirements for safety-Collateral Standard: Usability Edition 3.0, 2010	Compliant with usability requirements for medical electrical equipment.
IEC 62366 Medical devices Application of usability engineering to medical devices Edition 1.0, 2007	Compliant with usability engineering application for medical devices.
Labeling/Documentation
ISO 7176-15:1996, Wheelchairs Part 15: Requirements for information disclosure, documentation and labeling	Compliant with information disclosure, documentation, and labeling requirements.
Material Safety
ISO 7176-16, Second edition 2012-12-01, Wheelchairs Part 16: Resistance to ignition of postural support devices	Compliant with resistance to ignition of postural support devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "performance and safety tests" but does not specify the sample size for these tests. It is implied that tests were performed on the device itself (Solax Electric Scooter models S302121, S302131, S302141, S302151). This is a physical device, not an AI/ML algorithm processing data.

The data provenance is industrial testing of a physical product. The submitter is Dongguan Prestige Sporting Goods Co., Ltd. from China. The types of tests (ISO standards) are generally standardized laboratory or field tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a physical electric scooter, not an AI/ML diagnostic or predictive tool that requires expert consensus for ground truth on a test set. The "ground truth" for its performance is determined by adherence to the engineering and safety standards listed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies involving multiple readers for diagnostic tasks (e.g., radiologists interpreting images) to establish a consensus ground truth. This document describes the testing of a physical medical device against established engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. A MRMC comparative effectiveness study is relevant for AI/ML diagnostic or imaging devices where human performance with and without AI assistance is being evaluated. The Solax Electric Scooter is a physical mobility device and does not involve human readers interpreting data.

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

This information is not applicable. The Solax Electric Scooter is a physical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Solax Electric Scooter's performance is compliance with established international engineering and safety standards (ISO and IEC standards). These standards define performance limits and test methodologies, and the device is evaluated against these predefined criteria rather than a subjective "expert consensus" or biological "pathology" data set.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI/ML model that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable. As stated above, the device is not an AI/ML model requiring a training set with established ground truth.

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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 13, 2018

Dongguan Prestige Sporting Goods Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510663 CN

Re: K172440

Trade/Device Name: Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: April 29, 2018 Received: May 3, 2018

Dear Cassie Lee:

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. 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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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172440

Device Name

Solax Electric Scooter, Models: S302121, S302131, S302141, S302151

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.

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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter'sInformation

� 510(k) Owner's Name: Dongguan Prestige Sporting Goods Co., Ltd.
� Establishment Registration Number: 3008841035
Address: 3rd industrial, Qiaotou Area, Houjie Town, Dongguan City, Guangdong province, China �
� Tel: 13763128800
Fax:86-769-85922505 �
Contact Person: Zhang Zhao (General Manager) �
E-mail: leon@wisefame.com �

Application Correspondent: 2.

� Contact Person: Ms. Cassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. �
� Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China
Tel:+86-20-61099984 �
� Email: regulatory@glomed-info.com

3. Subject Device Information

Trade Name:	Solax Electric ScooterModel: S302121, S302131, S302141, S302151
Common Name:	Scooter
Classification name:	Vehicle, Motorized 3-Wheeled
Review Panel:	Physical Medicine
Product Code:	INI
Regulation Class:	2
Regulation Number:	890.3800

Predicate Device Information 4.

Sponsor	Dongguan Prestige Sporting Goods Co., Ltd.
Device Name	MOBIE scooter

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510(k) Number	K122749
Product Code	INI
Regulation Number	890.3800
Regulation Class	2

5. DeviceDescription

6. Intended Use / Indications for Use

lt 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.

7. Tests Summary

The following performance and safety tests were conducted with Solax Electric Scooter:

ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability
ISO 7176-2:2001, 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: 2001, Wheelchairs Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs
ISO 7176-7, First Edition 1998-05-15, 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

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ISO 7176-11, Second edition 2012-12-01, Wheelchairs Part 11: Test dummies
ISO 7176-13, First edition 1989-08-01, Wheelchairs Part 13: Determination 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, Second edition 2012-12-01, Wheelchairs Part 16: Resistance to ignition of postural support devices
ISO 7176-21 Second edition 2009-04-01 Wheelchairs Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
· IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes.
· IEC 60601-1-6 Medical electrical equipment-Part1-6: General requirements for safety-Collateral Standard: Usability Edition 3.0, 2010
· IEC 62366 Medical devices Application of usability engineering to medical devices Edition 1.0, 2007

The materials and manufacturing used for the Solax Electric Scooter are identical to those of the predicate device, which were demonstrated to conform with the following biocompatibility standards:

· ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for In Vitro cytotoxicity
· ISO 10993-10: 2009, Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity

8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Solax Electric Scooter is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

ElementsofComparison	Predicate Device	Subject Device	Remark
Proprietaryname	MOBIE scooter	Solax Electric Scooter	--
Model	Mobie	S302121, S302131, S302141,S302151	--
510K Number	K122749	K172440	--
Common orUsual name	Electrical scooter	Electrical scooter	--

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Intended use	It is a motor driven, indoor and outdoortransportation vehicle with the intendeduse to provide mobility to a disabled orelderly person limited to a seatedposition.	It is a motor driven, indoor and outdoortransportation vehicle with the intendeduse to provide mobility to a disabled orelderly person limited to a seatedposition.	SE
Size (unfold)	980450985mm	930450865mm	SENote
Tires	6 inches for front wheel (solid wheel)7 inches for rear wheel (solid wheel)	6 inches for front wheel (solid wheel)7 inches for rear wheel (solid wheel)	SENote
Speed	6 km/h (3.7mph)	6 km/h (3.7mph)	SE
Safe Gradient /MaximumGradient	0-13°	0-12°	SENote
Range	15 km (9.32mile)	15 km (9.32mile)	SE
Turning circle	1.4 m	1.55 m	SEnote
Baseweight(notincludingbattery)	25 kg	24 kg	SENote
Battery weight	1.84 kg	1.84 kg	SE
Brake	Electromagnetic	Electromagnetic	SE
Drive system	PG 45A / Rear wheel drive	PG 45A / Rear wheel drive	SE
Maximumcapacity	136 kg Approx.	125 kg Approx.	SENote
Groundclearance	36 mm	36 mm	SE
ObstacleClimbing Ability	38 mm	38 mm	SE
Battery	Lithium battery24V/10AH	Lithium battery24V/10AH	SE
Motor	24V 120W	24V 120W	SE
Battery charger	DC24V/2A	DC24V/2A	SE
Biocompatibility	All user directly contacting materialsare compliance with ISO10993-5 andISO10993-10 requirements.	All user directly contacting materialsare compliance with ISO10993-5 andISO10993-10 requirements.	SE
EMC	ISO 7176 - 21	ISO 7176 - 21	SE
Performance	ISO 7176 series	ISO 7176 series	SE

Comparison in Detail(s):

Note :

The design and technological characteristics of the Solax Electric Scooter is basically similar to the predicate device chosen. There are minor differences between the devices including overall dimensions, Safe Gradient, Turning circle, Maximum capacity, Ground clearance, Battery and motor. There is no deleterious effect on safety and effectiveness due to the differences, and these minor differences do not influence the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not

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raise any questions as to the safety and effectiveness. Therefore, the Solax Electric Scooter is substantially equivalent to the MOBIE (K122749).

9. Date of the summary prepared: July 11, 2018

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).