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

The PS30 Scooter has a base with aluminum allov frame, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable lithium Battery 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 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.

The scooter is provided in four colors - cherry Red, Neptune Blue, Sunburst Orange, Frozen Grey Mat, for the outer shell of wheels and consoler panel.

AI/ML Overview

The provided document is a 510(k) summary for the Scooter (PS30) and does not describe acceptance criteria or a study that proves a device meets acceptance criteria in the manner requested (i.e., for a medical device involving AI/machine learning, expert consensus, or complex clinical endpoints).

Instead, this document focuses on demonstrating substantial equivalence to a predicate device (K182471) for a motorized three-wheeled vehicle. The "acceptance criteria" here are essentially compliance with a comprehensive set of ISO and IEC standards relevant to wheelchairs and scooters, and the "study" is a series of non-clinical tests verifying that the device meets these standards and its design specifications.

Therefore, many of the specific details requested (like number of experts, adjudication methods, MRMC study, sample size for training set, ground truth establishment) are not applicable to this type of submission.

Below is an attempt to structure the available information into the requested format, clearly indicating when a category is not applicable based on the provided text.

Acceptance Criteria and Performance Study for Lichtmega Technology Co., Ltd.'s Scooter (PS30)

The "acceptance criteria" for the Scooter (PS30) are based on demonstrating compliance with a comprehensive set of ISO and IEC standards that address various aspects of electric wheelchairs and scooters, including stability, braking, energy consumption, dimensions, speed, strength, climatic performance, obstacle climbing, power/control systems, and electromagnetic compatibility. The "study" consisted of non-clinical tests to verify that the device met these standards and its design specifications.

1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance

Acceptance Criteria Category/Standard	Specific Criteria/Requirements (Implied by standard)	Reported Device Performance/Conclusion
Safety & Performance Standards (Non-clinical tests conducted to comply with all below)		"Non-clinical tests were conducted to verify that the subject device met all design specifications and provided support of the substantial equivalence determination. The test results demonstrated that the proposed device complies with the following standards."
ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability	Device meets static stability requirements.	Complies
ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability	Device meets dynamic stability requirements for electric wheelchairs.	Complies
ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes	Brakes meet effectiveness requirements.	Complies
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption	Energy consumption meets standards for theoretical distance range.	Complies
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass, maneuvering space	Dimensions, mass, and maneuvering space meet specified criteria.	Complies
ISO 7176-6:2018 Wheelchairs - Part 6: Maximum speed, acceleration, deceleration	Speed, acceleration, and deceleration meet requirements.	Complies
ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions	Seating and wheel dimensions comply.	Complies
ISO 7176-8:2014 Wheelchairs - Part 8: Static, impact, fatigue strength	Strength (static, impact, fatigue) meets requirements.	Complies S S S S S S S S S S
ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric wheelchairs	Performance under climatic conditions meets requirements.	Complies
ISO 7176-10:2008 Wheelchairs - Part 10: Obstacle-climbing ability	Obstacle-climbing ability meets requirements.	Complies
ISO 7176-11:2012 Wheelchairs -- Part 11: Test dummies	Use of appropriate test dummies for evaluation.	Complies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction	Coefficient of friction of test surfaces meets standards.	Complies
ISO 7176-14:2022 Wheelchairs -- Part 14: Power and control systems	Power and control systems meet requirements and test methods.	Complies
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure	Information disclosure, documentation, and labeling meet requirements.	Complies
ISO 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition	Postural support devices meet resistance to ignition requirements.	Complies
ISO 7176-21:2009 Wheelchairs - Part 21: Electromagnetic compatibility (EMC)	EMC characteristics meet requirements for electrically powered wheelchairs and scooters.	Complies
ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures	Set-up procedures comply with standards.	Complies
ISO 7176-25:2013 Wheelchairs - Batteries and chargers	Batteries and chargers meet requirements for powered wheelchairs.	Complies
IEC 60601-1-2:2020 Electromagnetic Compatibility Testing	EMC for medical electrical equipment complies with requirements.	Complies

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in terms of a "test set" as would be for clinical data. The tests are non-clinical, implying destructive/non-destructive testing of the device itself or its components. The document implies that at least one unit of the Scooter (PS30) and its components were subjected to these tests.
Data Provenance: The tests were conducted to specific international standards (ISO, IEC), likely in a testing laboratory. The country of origin for the testing data is not explicitly stated, but the applicant and correspondent are based in Shanghai, China. The data is retrospective in the sense that the tests were completed before the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a non-clinical device that does not involve expert interpretation or ground truth establishment in the diagnostic sense. Compliance with engineering standards is determined by test results against predefined limits, not expert consensus.

4. Adjudication method for the test set:

Not Applicable. See point 3. The verification primarily involves physical and electrical measurements compared to standard specifications.

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

Not Applicable. This device is a mobility scooter and does not incorporate AI or involve human interpretation of medical images/data.

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

Not Applicable. This device is a mechanical and electrical product, not an algorithm.

7. The type of ground truth used:

Engineering Standards and Design Specifications. The "ground truth" for this submission is established by the requirements outlined in the cited ISO and IEC performance and safety standards, as well as the device's own design specifications. The non-clinical tests verify that the device's performance aligns with these objective, measurable standards.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device; therefore, there is no concept of a "training set."

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

Not Applicable. See point 8.

Summary

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December 20, 2024

Lichtmega Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, Dongfang Building, 1500# Century Ave Shanghai. 200122 China

Re: K242628/S001

Trade/Device Name: Scooter (PS30) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: December 3, 2024 Received: December 3, 2024

Dear Ivy Wang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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 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

Submission Number (if known)

K242628

Device Name

Scooter (PS30)

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) #: K242628			510(k) Summary	Prepared on: 2024-12-03
Contact Details				21 CFR 807.92(a)(1)
Applicant Name		Lichtmega Technology CO., Ltd.
Applicant Address		#101, No. 200, Cangjing Road, Songjiang District Shanghai ShanghaiChina
Applicant Contact Telephone		+86-021-578986
Applicant Contact		Mr. Hyman Zhu
Applicant Contact Email		Hyman@lichtmega.com
Correspondent Name			Shanghai Sungo Management Consulting Company Limited
Correspondent Address			14th Floor, Dongfang Building, 1500# Century Ave Shanghai 200122China
Correspondent Contact Telephone			+86-58817802
Correspondent Contact			Ms. Ivy Wang
Correspondent Contact Email			haiyu.wang@sungoglobal.com
Device Name				21 CFR 807.92(a)(2)
Device Trade Name		Scooter (PS30)
Common Name		Motorized three-wheeled vehicle
Classification Name		Vehicle, Motorized 3-Wheeled
Regulation Number		890.3800
Product Code(s)		INI
Legally Marketed Predicate Devices				21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)			Product Code
K182471	Scooter			INI
Device Description Summary				21 CFR 807.92(a)(4)

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

The scooter is provided in four colors - cherry Red, Neptune Blue, Sunburst Orange, Frozen Grey Mat, for the outer shell of wheels and consoler panel.

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.

Indications for Use Comparison

The proposed device has same indications for use to the predicate device.

Technological Comparison

The design and technological characteristics of the proposed device scooter is identical to the predicate device. There are minor differences between the device is the dimension, frame material, travel distance, turning radius, ground clearance, controller, tire dimension, slope grade ability, maximum speed and loading weight. According to ISO7176 series standards and the test records support its safety and effectiveness. There is no deleterious 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 (K182471).

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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Non-clinical tests were conducted to verify that the subject device met all design specifications and provided support of the substantial equivalence determination. The test results demonstrated that the proposed device complies with the following standards: ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability ISO 7176-2:2017 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs ISO 7176-3:2012 Wheelchairs - Part 3: Determination of effectiveness of brakes ISO 7176-42008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and maneuvering space ISO 7176-6:2018 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions ISO 7176-8:2014 Wheelchairs - Part 8: Requirements and test methods for static, impact and fatique strength ISO 7176-9:2009 Wheelchairs - Part 9: Climatic tests for electric 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 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces. ISO 7176-14:2022 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 16840-10:2021 Wheelchair seating - Part 10: Resistance to ignition of postural support devices – Requirements and test method ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters ISO 7176-22: 2014 Wheelchairs - Part 22: Set-up procedures ISO 7176-25:2013 Wheelchairs - Batteries and chargers for powered wheelchairs Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2020.

The clinical study is not applicable.

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device 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).