Electric Scooter (FNS01,FNS03)

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 24, 2026 Anhui Jbh Medical Apparatus Co., Ltd. % Amos Zou Medical Device Consultant Huide Medical Technology Service Group Co., Ltd. Rm. 703, Bldg. 16, S. Bank Plz., Exhibition Bay Zhancheng Community, Fuhai St., Bao'An District Shenzhen, Guangdong 518053 China Re: K261078 Trade/Device Name: Electric Scooter (FNS01, FNS03) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: April 1, 2026 Received: April 1, 2026 Dear Amos Zou: 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. Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261078 - Amos Zou Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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-assistance) {2} K261078 - Amos Zou 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, **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 {3} | 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. | K261078 | ? | | Please provide the device trade name(s). | | ? | | Electric Scooter (FNS01,FNS03) | | | | Please provide your Indications for Use below. | | ? | | The Electric Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position. | | | | Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} # 510(k) Summary ## -K261078 ### 1. Submitter Information Sponsor: | Item | Information | | --- | --- | | Submitter's Name | Anhui JBH Medical Apparatus Co., Ltd. | | Address | # 116 Qicang Rd., Industrial District, Ming Guang City, Chuzhou, Anhui, CN | | Contact Person | Yuanwei Wei | | Phone Number | +86-0550-8108866 | | Email | outreach@jbhmedical.com | Application Correspondent: | Item | Information | | --- | --- | | Company Name | Huide Medical Technology Service Group Co., Ltd | | Address | Room 703, Building 16, South Bank Plaza, Exhibition Bay, Zhancheng Community, Fuhai Street, Shenzhen, Guangdong, 518053, China | | Contact Person | Mr. Amos Zou | | TEL | +86-15015249549 | | E-mail | 546977693@qq.com | | Prepared Date | August 23, 2026 | ### 2. Device Identification | Item | Subject Device 1 | Subject Device 2 | | --- | --- | --- | | Device Trade Name | Electric Scooter (Model: FNS01) | Electric Scooter (Model: FNS03) | | Common Name | Motorized Vehicle / Electric Scooter | Motorized Vehicle / Electric Scooter | | Classification Name | Vehicle, Motorized 3-Wheeled | Vehicle, Motorized 3-Wheeled | | Regulation Number | 21 CFR 890.3800 | 21 CFR 890.3800 | | Regulatory Class | Class II | Class II | | Product Code | INI | INI | | Panel | Physical Medicine | Physical Medicine | ### 3. Predicate Device Information | Item | Predicate Device | | --- | --- | | 510(k) Number | K252349 | | Device Name | Electric Scooter (Model: Mojo-T330) | | Manufacturer | Dongguan Smarfody Mobility Technology Co., Ltd. | {5} | Product Code | INI | | --- | --- | | Regulation Number | 21 CFR 890.3800 | | Regulatory Class | Class II | The predicate device has not been subject to a design-related recall. ### 4. Device Description The subject devices (FNS01 and FNS03) are motor-driven, indoor and outdoor transportation vehicles designed to provide mobility to persons restricted to a sitting position. FNS01 (4-Wheel Model): The device consists of an aluminium alloy frame, 4 wheels (Front: 6.3" PU solid, Rear: 7.5" PU solid), a seat, a control panel (tiller), a 120W electric motor, an electromagnetic brake system, dual rechargeable Lithium-ion batteries (24V 6AH x 2 pcs), an off-board charger, and a Bluetooth BLE 5.0 module with a dedicated Bluetooth key (remote controller). The device features a manual folding mechanism for portability. FNS03 (3-Wheel Model): The device consists of an aluminium alloy frame, 3 wheels (Front: 8" PU solid, Rear: 7.5" PU solid), a seat, a control panel (tiller), a 150W electric motor, an electromagnetic brake system, a single rechargeable Lithium-ion battery (24V 6AH x 1 pc), and an off-board charger. The device has no Bluetooth function and relies solely on on-board manual/electric controls. The device features a manual folding mechanism for portability. Control System: The movement is controlled by the rider via a control lever. The FNS01 model additionally incorporates a Bluetooth BLE 5.0 module with a dedicated Bluetooth key (remote controller). This remote control function enables the user to remotely power the scooter on/off, fold/unfold, and lock/unlock it, providing convenient remote operation for users with limited mobility who may have difficulty reaching or operating the control panel. The Bluetooth key has no network capability; the device has no internet connectivity and no over-the-air (OTA) update path. The electromagnetic brake engages automatically when the scooter is not in use or the control lever is released. ### 5. Indications for Use The Electric Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position. ### 6. Technological Characteristics Comparison The subject devices share the same fundamental technological characteristics and design principles as the predicate device (K252349). A detailed comparison is provided below: | Elements of Comparison | Subject Device (FNS01) | Subject Device (FNS03) | Predicate Device (K252349) | Comparison Result | | --- | --- | --- | --- | --- | | Indications for Use | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position | The device is intended for medical purposes to provide mobility to persons restricted to a sitting position | Same | | Regulation Number | 21 CFR 890.3800 | 21 CFR 890.3800 | 21 CFR 890.3800 | Same | | Product Code | INI | INI | INI | Same | | Classification | Class II | Class II | Class II | Same | | Number of Wheels | 4 Wheels | 3 Wheels | 4 Wheels | Similar | | Foldable Mechanism | Yes (Manual Folding) | Yes (Manual Folding) | Yes (Foldable) | Same | | Maximum Loading | 120 kg | 120 kg | 120 kg | Same | | Maximum Speed | 6 km/h | 6 km/h | 6 km/h | Same | {6} | Power Source | Rechargeable Li-ion Battery | Rechargeable Li-ion Battery | Rechargeable Li-ion Battery | Same | | --- | --- | --- | --- | --- | | Brake System | Electromagnetic Brake | Electromagnetic Brake | Electromagnetic Brake | Same | | Control Method | Tiller/Control Lever | Tiller/Control Lever | Tiller/Control Lever | Same | | Wireless Communication / Remote Control | Bluetooth BLE 5.0 remote control (dedicated Bluetooth key) | None | None | Different (FNS01 only) | | Frame Material | Aluminium Alloy | Aluminium Alloy | Metal frame | Similar | | Motor Power | 120W | 150W | Electric motor | Similar | | Battery Configuration | 24V 6AH x 2 pcs | 24V 6AH x 1 pc | 1 rechargeable Li-ion Battery | Similar | | Device Dimensions — Unfolded (L×W×H) | 946 × 495 × 926 mm | 1010 × 525 × (830–1030) mm | 1120 × 580 × 700 mm | Similar | | Device Dimensions — Folded (L×W×H) | 418 × 495 × 693 mm | 360 × 525 × 650 mm | 730 × 450 × 420 mm | Similar | | Ground Clearance | 20 mm | 65mm | Not specified in predicate labeling | — | | Front Wheel Size & Type | 6.3 in (163 × 50 mm) PU solid | 8 in (200 mm) PU solid | ~7 in (175 × 40 mm) | Similar | | Rear Wheel Size & Type | 7.5 in (190 × 54 mm) PU solid | 7.5 in (190 × 54 mm) PU solid | ~7 in | Similar | | Max. Travel Distance (full charge) | 15.6 km | 15 km (1 batt.) / 30 km (2 batt.) | Not specified in predicate labeling | — | | Minimum Braking Distance | ≤1.0 m (level) / ≤1.6 m (3°) | ≤1.0 m / ≤1.6 m [not in IFU] | Not specified in predicate labeling | — | | Maximum Safe Operation Incline | 8° | 6° | Not specified in predicate labeling | — | | Minimum Turning Radius | 1200 mm | 1000 mm | Not specified in predicate labeling | — | | Maximum Obstacle Climbing | 20 mm height / 100 mm gap | 25 mm height / 100 mm gap | Not specified in predicate labeling | — | ### Remark: Based on the comparison and analysis above: 1. The subject devices (FNS01 and FNS03) have the same intended use as the predicate device (K252349). 2. The subject devices share the same fundamental technological characteristics as the predicate (power source, braking system, control mechanism, and folding design) and the same regulatory classification. 3. The key safety and performance parameters — maximum load (120 kg) and maximum speed (6 km/h) — are identical to the predicate. 4. The differences in technological characteristics (number of wheels, device dimensions and folded size, ground clearance, front/rear wheel size and type, maximum travel distance, minimum braking distance, maximum safe operation incline, minimum turning radius, maximum obstacle climbing, motor power, and battery configuration) are minor design variations that do not affect safety or effectiveness. In addition, FNS01 integrates a Bluetooth BLE 5.0 remote-control function (via a dedicated Bluetooth key) that the predicate does not have; this function has been verified through dedicated remote-control testing and a complete cybersecurity assessment and does not introduce any new safety or effectiveness concern. {7} ## 7. Non-Clinical and/or Clinical Tests Summary & Conclusions To demonstrate substantial equivalence, the subject devices (FNS01 and FNS03) were tested in accordance with recognized consensus standards and FDA guidance. The testing included: ### 7.1 Performance Testing The devices were tested according to the ISO 7176 series standards and EN 12184:2022. Test results demonstrated that the subject devices perform as intended and are substantially equivalent to the predicate device regarding: - Static and Dynamic Stability (Scooter tipping angle, Safe Gradient) - Brake Performance - Maximum Speed (6 km/h) and Theoretical Distance Range - Dimensions and Weight - Obstacle-climbing Ability - Static, Impact, and Fatigue Strengths - Climatic Tests - Power and Control Systems - Flammability / Resistance to Ignition (ISO 16840-10:2021/Amd.1:2024) ### 7.2 Biocompatibility The biocompatibility evaluation for the subject device was conducted in accordance with Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". As dictated by the nature of body contact (intact skin) and contact duration (More than 30 days), the following endpoints were evaluated for the components that come into direct contact with the user (e.g., grips): 1) ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity 2) ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization 3) ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices - Part 23: Tests for irritation The results of these test demonstrated that the patient-contacting components of the subject device are non-cytotoxic, non-sensitizing, and non-irritating. ### 7.3 Electrical Safety and EMC The devices comply with applicable electrical safety and electromagnetic compatibility standards. EMC testing (IEC 60601-1-2 Edition 4.1 2020-09; IEC TS 60601-4-2 Edition 1.0 2024-03) demonstrates compliance with emission and immunity requirements, confirming the device does not interfere with other medical equipment and operates safely in its intended environment. ### 7.4 Software Verification and Validation Testing In compliance with the requirements specified in the U.S. Food and Drug Administration (FDA) guidance document for industry and FDA staff—Content of Premarket Submissions for Device Software Functions—Software System testing results provided in this 510(k) demonstrate that all software requirement specifications have been met, and all software-related hazards have been mitigated to acceptable risk levels. The software verification and validation documentation includes dedicated remote-control (Bluetooth key) testing for the FNS01 model, covering power on/off, fold/unfold, pairing, AES encryption, fault injection, and misoperation prevention. {8} ## 7.5 Cybersecurity The FNS01 model incorporates a Bluetooth BLE 5.0 interface (dedicated Bluetooth key remote controller). In accordance with Section 524B of the FD&C Act and the FDA guidance "Cybersecurity in Medical Devices", a complete cybersecurity documentation set was provided, including a threat model (STRIDE), a cybersecurity risk assessment (CVSS 4.0 + NIST SP 800-30 R3), a Software Bill of Materials (SBOM), architecture views, cybersecurity controls, cybersecurity testing, cybersecurity labeling, and a cybersecurity management plan. Third-party penetration testing identified 11 low-severity findings, all assessed as acceptable. The device is a standalone, offline device with no internet connectivity; its attack surface is limited to the Bluetooth pairing interface and the physical offline firmware update interface. ## 7.6 Summary of Clinical Performance Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively. ## 8. Substantial Equivalence Conclusion The subject devices (Electric Scooter, Models FNS01 and FNS03) have the same intended use as the legally marketed predicate device (K252349, Mojo-T330). The subject devices and the predicate share the same core design principle, safety mechanisms, and regulatory classification. All differences — including wheel configuration, device and folded dimensions, ground clearance, wheel size and type, travel distance, braking distance, operation incline, turning radius, obstacle-climbing capability, motor power, and battery configuration, as well as the Bluetooth BLE 5.0 remote-control function present in FNS01 but absent from the predicate — have been adequately addressed through design control, risk analysis, performance testing (per ISO 7176 series and EN 12184), and, for the wireless function, dedicated remote-control testing and a complete cybersecurity assessment. These differences do not affect the safety or effectiveness of the device. Accordingly, the subject devices are Substantially Equivalent to the predicate device.