Electric Scooter (FDB08, FDB08A, FDB12)

{0} **U.S. FOOD & DRUG** ADMINISTRATION September 19, 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: K261859 Trade/Device Name: Electric Scooter (FDB08, FDB08A, FDB12) Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized Three-Wheeled Vehicle Regulatory Class: Class II Product Code: INI Dated: August 20, 2026 Received: August 20, 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261859 - Amos Zou Page 2 (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/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). {2} K261859 - Amos Zou Page 3 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. | K261859 | ? | | Please provide the device trade name(s). | | ? | | Electric Scooter (FDB08, FDB08A, FDB12) | | | | Please provide your Indications for Use below. | | ? | | 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. | | | | 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 ## -K261859 1. Submitter Information Sponsor : | 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: | 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 : | 2026-09-17 | 2. Device Information | Item | Content | | --- | --- | | Trade Name | Electric Scooter | | Common Name | Power Scooter / Electric Mobility Scooter | | Classification Name | Motorized Three-Wheeled Vehicle | | Model(s) | FDB08, FDB08A, FDB12 | {5} | Product Code | INI | | --- | --- | | Regulation Number | 21 CFR 890.3800 | | Regulatory Class | Class II | ### 3. Predicate Device Information | Item | Predicate Device | | --- | --- | | 510(k) Number | K242387 | | Device Name | Mobility Scooter (Model: N3473) | | Manufacturer | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | | 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 in the FDB series (FDB08, FDB08A, and FDB12) are motor-driven, indoor and outdoor transportation vehicles designed to provide mobility to persons restricted to a sitting position. These devices are intended for use on firm, level surfaces indoors and paved pathways outdoors, with gentle slopes up to 8°. FDB08: The device consists of an aluminium alloy frame, 4 wheels (Front: 8" PU solid, Rear: 7.5" PU solid), a seat, a control panel (tiller), a 300W electric motor, an electromagnetic brake system, a rechargeable Lithium-ion battery (24V 45AH x 1 pc), and an off-board charger. FDB08A: The device consists of an aluminium alloy frame, 4 wheels (Front: 8" PU solid, Rear: 7.5" PU solid), a seat, a control panel (tiller), a 400W electric motor, an electromagnetic brake system, a rechargeable Lithium-ion battery (24V 60AH x 1 pc), and an off-board charger. FDB12: The device consists of an aluminium alloy frame, 4 wheels (Front: 8" PU solid, Rear: 7.5" PU solid), a full-featured seat with adjustable backrest and suspension, a control panel (tiller), a 500W electric motor, an electromagnetic brake system, a rechargeable Lithium-ion battery (24V 65AH x 1 pc), and an off-board charger. Control System: The movement of all FDB series models is controlled by the rider via a control lever (joystick) on the tiller console. The electromagnetic brake engages automatically when the scooter is not in {6} use or the control lever is released, ensuring safe operation. ## 5. Intended Use / Indication for Use 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. ## 6. Comparison with Predicate Device The subject devices (FDB08, FDB08A, FDB12) have been compared with the predicate device (K242387). A detailed comparison is provided below: | Elements of Comparison | FDB08 (Subject Device) | FDB08A (Subject Device) | FDB12 (Subject Device) | Predicate Device N3473 (K242387) | Comparison Result | | --- | --- | --- | --- | --- | --- | | Number of Wheels | 4 Wheels | 4 Wheels | 4 Wheels | 4 Wheels | Same | | Foldable Mechanism | No | No | No | Yes (Foldable) | Similar | | Maximum Loading | 120 kg | 120 kg | 150 kg | 120 kg | Similar | | Maximum Speed | ≤6 km/h | ≤6 km/h | ≤6 km/h | 6 km/h | Same | | Power Source | Rechargeable Li-ion Battery | Rechargeable Li-ion Battery | Rechargeable Li-ion Battery | Rechargeable Li-ion Battery | Same | | Brake System | Electromagnetic Brake | Electromagnetic Brake | Electromagnetic Brake | Electromagnetic Brake | Same | | Control Method | Tiller/Control Lever | Tiller/Control Lever | Tiller/Control Lever | Tiller/Control Lever | Same | | Frame Material | Aluminium Alloy | Aluminium Alloy | Aluminium Alloy | Magnesium Alloy | Similar | | Motor Power | 300W | 400W | 500W | 150W | Similar | | Battery Configuration | 24V 45AH x 1 pc | 24V 60AH x 1 pc | 24V 65AH x 1 pc | 24V 12AH x 1 pc | Similar | {7} | Device Dimensions – Unfolded (L× W×H) | 1020×480× 915 mm | 1020×480× 915 mm | 1020×480× 915 mm | 1050×550× 870 mm | Differen t | | --- | --- | --- | --- | --- | --- | | Device Dimensions – Folded (L×W ×H) | 1020×480× 445 mm | 1020×480× 445 mm | 1020×480× 445 mm | Not specified | Differen t | | Ground Clearance | 40mm | 40mm | 40mm | 50 mm | Differen t | | Front Wheel (size & type) | 175×45mm (≈ 6.9") PU solid | 175×45mm PU solid | 175×45mm PU solid | 7" solid | Similar | | Rear Wheel (size & type) | 200×45mm (≈ 7.9") PU solid | 200×45mm PU solid | 200×45mm PU solid | 8" solid | Similar | | Max. Distance (full charge) | 14 km | 14 km | 14 km | 20 km | Differen t | | Min. Braking Distance | 500mm | 500mm | 500mm | 1100 mm | Similar | | Max. Safe Operation Incline | Max 8° | Max 8° | Max 8° | 6° | Differen t | | Min. Turning Radius | 1300 mm | 1300 mm | 1300 mm | 1350 mm | Differen t | | Max. Obstacle Climbing | 20mm | 25mm | 25mm | 15mm | Differen t | # Remark: Based on the comparison and analysis above: 1. The subject devices (FDB08, FDB08A, FDB12) have the same intended use as the predicate device (K242387). {8} 2. The subject devices share the same technological characteristics (power source, braking system, control mechanism) and same regulatory classification. 3. The key safety and performance parameters—Maximum Loading (FDB08 and FDB08A, and 150 kg for FDB12) and Maximum Speed (6 km/h)—are equal or similar to those of the predicate device. 4. Minor differences in technological characteristics (motor power, battery capacity, frame material, folding mechanism, device dimensions, wheel size, ground clearance, maximum distance, braking distance, safe operation incline, turning radius and obstacle-climbing ability) have been thoroughly evaluated through performance testing. These differences do not affect safety or effectiveness and do not raise different questions of safety and effectiveness than the predicate device. ### 7. Non-Clinical and/or Clinical Tests Summary & Conclusions To demonstrate substantial equivalence, the subject devices (FDB08, FDB08A, FDB12) 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 ### 7.2. Biocompatibility Testing This device is intended for contact with intact skin only. According to the recommendations of Attachment G of the FDA guidance, routine ISO 10993-1 biological testing (e.g., cytotoxicity, sensitization, irritation) is not necessary for materials that have a documented history of safe use and are listed as synthetic polymers in Attachment G. All patient-contacting components of this device are composed of such materials: - Seat & Back Cushion / Armrest: Polyurethane (PUR) foam and/or artificial leather (Polyurethane coated fabric). {9} - Hand Grips / Joystick: Acrylonitrile Butadiene Styrene (ABS) plastic and Silicone. All of the above materials (Polyurethane, ABS, and Silicone) are explicitly listed in Attachment G. The evaluation has confirmed a history of safe use for these materials in medical and mobility devices for intact skin contact. Therefore, pursuant to the findings of the ISO 10993-1 Biological Evaluation Report (JBH-BER-001), routine ISO 10993 testing for cytotoxicity, sensitization, and irritation is considered exempt. No specific biocompatibility testing was required or performed for these materials. The device is considered biocompatible for its intended use. ### 7.3. Electrical Safety and EMC Testing 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. This device does not incorporate wireless technology; therefore, the FDA RF Wireless Guidelines do not apply. ### 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. ### 7.5 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 FDB08, FDB08A, FDB12) share the same intended use as the legally marketed predicate device (K242387). In terms of technological characteristics, they share the same core design principles, safety mechanisms, and regulatory classification. Any differences (such as motor power, battery configuration, frame material, folding mechanism) have been fully justified through design controls and risk analysis, and verified via testing to not impact the overall safety and effectiveness of the devices. Therefore, the subject devices are deemed to be Substantially Equivalent to the selected predicate device.