(114 days)
No
The device description and performance studies focus on mechanical, electrical, and standard safety/performance aspects of a mobility scooter, with no mention of AI or ML capabilities.
Yes
The device is described as assisting people restricted to a sitting position, which aligns with the definition of a therapeutic device designed to alleviate or manage a medical condition or disability.
No
The device is a mobility scooter designed to assist people with movement, not to diagnose medical conditions or diseases.
No
The device description explicitly lists numerous hardware components (steel frame, wheels, seat, motor, batteries, etc.) and describes physical performance testing, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Mobility Scooter Function: The description clearly states the mobility scooter is intended for "providing assistance to people restricted to a sitting position" and is "driven by the end users for movement." It's a device for physical mobility, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, analyzing, or testing biological samples. There's no mention of reagents, analyzers, or any diagnostic purpose.
The device described is a mobility aid, which falls under a different category of medical devices.
N/A
Intended Use / Indications for Use
The mobility scooter is intended for providing assistance to people restricted to a sitting position.
Product codes
INI
Device Description
The mobility scooter mainly consists of steal frame, two front wheels, two rear wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, front lights, two rechargeable Lead-acid Batteries, and a battery charger. The product is intended to be used for assisting people restricted to a sitting position. It is driven by the end users for movement. It is compact, maneuverable but not necessarily able to overcome obstacles. The maximum load is 150 kg. It is powered by rechargeable batteries with 25.3 km theoretical distance range which maximum speed up to 10.5 km/h (tested value).
The scooter is highly recommended to be driven on flat roads. Frequent usage of the scooter on slopes, rough terrain, or when climbing curbs will result in a reduction of driving distance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PERFORMANCE TESTING
- (1) EMC report was conducted according to ISO 7176-21:2009, IEC 60601-1-2: 2014+A1:2020, and IEC TR 60601-4-2:2016.
- (2) Physical properties were conducted according to the following standards serials.
- ISO 7176-1:2014, Static stability
- ISO 7176-2:2017, Dynamic stability
- ISO 7176-3: 2012, Effectiveness of brakes
- ISO 7176-4:2008, Energy consumption and theoretical distance range
- ISO 7176-5:2008, Dimensions, mass and turning space
- ISO 7176-6:2018, Maximum speed, acceleration and deceleration
- ISO 7176-7:1998, Seating and wheel dimensions
- ISO 7176-8:2014, Static, Impact and fatigue strengths
- ISO 7176-9:2009, Climatic tests
- ISO 7176-10:2008, Obstacle-climbing ability
- ISO 7176-11:2012, Test dummies
- ISO 7176-13:1989, Coefficient of friction
- ISO 7176-14:2022, Power and control systems
- ISO 7176-15:1996, Information disclosure, documentation and labelling
- ISO 16840-10:2021, Resistance to ignition
- ISO 7176-22: 2014, Set up procedure
- ISO 7176-25: 2013, Battery and charger
The proposed device has different specifications for scooter components and performance compared to the predicate device. It underwent performance testing according to ISO 7176 series, and the results demonstrated that it met all the standard requirements. Therefore, both the proposed and predicate devices meet the performance testing standards, demonstrating the substantial equivalence.
BIOCOMPATIBILITY TESTING:
The proposed device was tested in compliance with the FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as the Surface device- Intact skin-Long term contact (>30 days).
The items listed below underwent testing in accordance with ISO 10993-1.
- Cytotoxicity
- Intracutaneous Reactivity
- Sensitization
PACKAGE VALIDATION
Package integrity testing under simulated shipping conditions was conducted to satisfy the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging was deemed acceptable for protection of product.
USABILITY AND HUMAN FACTOR
A usability and human factor testing was conducted to assess the usability of the scooter from the users' perspective by following the FDA guidance-Applying Human Factors and Usability Engineering to Medical Devices. The results of observation and questionnaire indicated that users were generally satisfied with the scooter's usage and new risks were identified to be monitored.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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April 18, 2024
Yongkang Yile Vehicle Co., Ltd. % Evan Hu Technical and Regulatory Director Shanghai Mind-link Consulting Co., Ltd. 377 Tianzhu Road, Jiading Shanghai, 201801 China
Re: K234098
Trade/Device Name: Mobility Scooter (C4+) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: December 22, 2023 Received: December 26, 2023
Dear Evan Hu:
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.
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"
1
(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 OS 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 Rehabilitation Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K234098
Device Name Mobility Scooter (C4+)
Indications for Use (Describe)
The mobility scooter is intended for providing assistance to people restricted to a sitting 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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4
510(k) Summary
K234098
1. Preparation date: Dec. 12th, 2023
2. Submitter
Manufacturer: YONGKANG YILE VEHICLE CO., LTD. Address: No.46 Zerong Road, Dahou Industrial Zone, Tangxian Town, Yongkang, Zhejiang, 321314, PRC Contact person: David SHI, Chief Manager, +86 15158900066, 41724003@gq.com Submission correspondent: Evan Hu, Technical and Regulatory Director, +86-18616124827, evan.ww.hu@outlook.com
3. Device
Trading name: Mobility Scooter (C4+) Common name: Scooter Regulation No.: 21 CFR 890.3800 Classification name: Vehicle, Motorized 3-Wheeled Classification: Class II Product code: INI
4. Predicate device
Predicate device: K132855 Trading name: HEARTWAY Power Mobility Scooter, S15 Common name: Scooter Regulation No.: 21 CFR 890.3800 Classification name: Vehicle, Motorized 3-Wheeled Classification: Class II Product code: INI
5. Device description
The mobility scooter mainly consists of steal frame, two front wheels, two rear wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, front lights, two rechargeable Lead-acid Batteries, and a battery charger. The product is intended to be used for assisting people restricted to a sitting position. It is driven by the end users for movement. It is compact, maneuverable but not necessarily able to overcome
5
obstacles. The maximum load is 150 kg. It is powered by rechargeable batteries with 25.3 km theoretical distance range which maximum speed up to 10.5 km/h (tested value).
The scooter is highly recommended to be driven on flat roads. Frequent usage of the scooter on slopes, rough terrain, or when climbing curbs will result in a reduction of driving distance.
6. Indications for use/Intended use
The mobility scooter is intended for providing assistance to people restricted to a sitting position.
7. Comparison of technological characters between proposed and predicate devices
| Items | Proposed device
(K-234098-Mobility Scooter, C4+) | Predicate device
(K132855-HEARTWAY Mobility Scooter, S15) | Comments |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Indications for use/Intended use | The mobility scooter is intended for providing assistance to people restricted to a sitting position. | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position. | #1 |
| Product code | INI | INI | Same |
| Frame and material | Folded, Cold rolled steel and seamless steel pipe | Folded, Carbon Steel Pipe | #2 |
| Overall dimension | Length * width * height:
1366mm * 665mm * 1323mm | Length * width * height:
1400mm * 700mm * 1360mm | #2 |
| Seat width | 460mm | 620mm | #2 |
| Seat height | 660mm | 820mm | #2 |
| Max occupant mass/Weight limit | 150kg | 160kg | #2 |
| Overall weight | w/ batteries 130Kg (w/o package)
w/o batteries 105Kg (w/o package) | w/ batteries 136Kg
w/o batteries 98Kg | #2 |
| Max speed | 10.5km/h (tested value)
12km/h (set value) | 9.6km/h | #2 |
| Batteries | Lead acid battery
Four batteries in two packs, 12V | Lead acid battery
Two batteries packs, 12V DC, 50Ah. | #2 |
| | DC, 20Ah. | | |
| Range per charge/
Energy consumption | 25.3km | 40km | #2 |
| Motor | 24V DC, 950W | 24V DC, 700 W | #2 |
| Controller | PG S-DRIVE | RHINO DS120 Drive | #6 |
| Brake | Electromagnetic brake | Electromagnetic brake | Same |
| Barking time and
distance | 30 days).
The items listed below underwent testing in accordance with ISO 10993-1.
- Cytotoxicity .
- Intracutaneous Reactivity -
- -Sensitization
PACKAGE VALIDATION
Package integrity testing under simulated shipping conditions was conducted to satisfy the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging was deemed acceptable for protection of product.
USABILITY AND HUMAN FACTOR
A usability and human factor testing was conducted to assess the usability of the scooter from the users' perspective by following the FDA guidance-Applying Human Factors and Usability Engineering to Medical Devices. The results of observation and questionnaire indicated that users were generally satisfied with the scooter's usage and new risks were identified to be monitored.
9. Clinical testing
Not applicable for this submission.
9
10. Conclusion
The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.