It is 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 proposed Mobility Scooter (BC-MS310) provide transport for the disabled and the elderly and to be used both indoors and outdoors. The maximum loading weight is 100kg.

The proposed scooter mainly consists of aluminum alloy frame, two front wheels, two rear wheels, a seat, a tiller console, pedal, a electric motor and one rechargeable Lithium battery with an off-board charger.

The device is powered by Li-ion battery, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use. Alternatively, the scooter can be charged directly through the tiller port on the control panel.

The patient can pull the right throttle control lever back with the right fingers to move forward the scooter and pull the left throttle control lever back with the left fingers to move backward the scooter. After the throttle control lever is released, the scooter will stop. The speed of the scooter could be adjusted according to the forward and backward degrees of the throttle control lever.

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 device can be folded up from front to back.

The scooters are designed to be a light and compact, smart mobility scooter. The tiller can be adjusted back and forth according to human comfort. The scooter can be manually folded and unfolded including the frames and seat just in one step. It can be put into the trunk of a small, compact car. The battery is removable.

AI/ML Overview

N/A

Summary

U.S. Food & Drug Administration

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.08.02
Silver Spring, MD 20993
www.fda.gov

January 2, 2026

Ningbo Baichen Medical Devices Co., LTD
℅ Ariel Xiang
Secondary Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China

Re: K252817
Trade/Device Name: Mobility Scooter (BC-MS310)
Regulation Number: 21 CFR 890.3800
Regulation Name: Motorized Three-Wheeled Vehicle
Regulatory Class: Class II
Product Code: INI
Dated: December 9, 2025
Received: December 9, 2025

Dear Ariel Xiang:

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.

FDA U.S. FOOD & DRUG ADMINISTRATION

January 2, 2026

Ningbo Baichen Medical Devices Co., LTD
℅ Ariel Xiang
Secondary Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China

Dear Ariel Xiang:

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Page 2

K252817 - Ariel Xiang 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K252817 - Ariel Xiang Page 3

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,

Digitally signed by MARY S. KESZLER -S
Date: 2026.01.02 11:07:49 -05'00'

for 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 Quality
Center for Devices and Radiological Health

Enclosure

Page 4

Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K252817

Please provide the device trade name(s). Mobility Scooter (BC-MS310)

Please provide your Indications for Use below.

It is 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.

Please select the types of uses (select one or both, as applicable).

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)

Page 5

510(k) Summary

510(k) #: K252817
Prepared on: 2025-12-09

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	NINGBO BAICHEN MEDICAL DEVICES CO., LTD
Applicant Address	Room 2101, No.666 Taikang Middle Road, Yinzhou District, Ningbo Zhejiang 315000 China
Applicant Contact Telephone	86-15158388666
Applicant Contact	Mr. Xiaolong Wu
Applicant Contact Email	alan@baichen.ltd
Correspondent Name	Shanghai SUNGO Management Consulting Co., Ltd.
Correspondent Address	Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China China
Correspondent Contact Telephone	+86-21-58817802
Correspondent Contact	Ms. Ariel Xiang
Correspondent Contact Email	shouqiu.xiang@sungoglobal.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Mobility Scooter (BC-MS310)
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
K250533	Mobility Scooter	INI

Device Description Summary

21 CFR 807.92(a)(4)

The proposed Mobility Scooter (BC-MS310) provide transport for the disabled and the elderly and to be used both indoors and outdoors. The maximum loading weight is 100kg.

Page 6

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

It is 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

21 CFR 807.92(a)(5)

The indications for use of the proposed device and the predicate device are the same.

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.

Technological Comparison

21 CFR 807.92(a)(6)

The design and technological characteristics of the proposed device scooter is similar to the predicate device. There are minor differences between the devices in frame material, size, load capacity, weight, ground clearance, turn radius, drive system, battery type, charger, controller, motor output, max speed, travel distance and total mass. All of the parameters with differences 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 equivalent (SE) to The Scooter (K250533).

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

H.Product Performance

H1 Performance of the products

The following performance data were provided to verify that the proposed device met all design specifications and provided support of the substantial equivalence determination.

Risk Analysis developed in accordance with ISO 14971: 2019.
Software validation
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 7176-4:2008 Wheelchairs - Part4: 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 fatigue 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

Page 7

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 - Part 25: Batteries and chargers for powered wheelchairs.
Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2 and IEC TR 60601-4-2
IEC 62133-2:2017+A1:2021 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

H2.Biocompatibility of patient-contacting material

The biocompatibility of the subject device is based on the use of low-risk biocompatible materials in Attachment G of FDA's 2023 Biocompatibility Guidance.

Not Applicable

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 (K250533).

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).