Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 27, 2025 Ningbo Baichen Medical Devices Co., Ltd % Luna Hu Official Correspondent Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave Shanghai, 200122 China Re: K250475 Trade/Device Name: Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 30, 2025 Received: February 21, 2025 Dear Luna 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250475 - Luna Hu 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- {2} K250475 - Luna Hu 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 Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250475 Device Name Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) Indications for Use (Describe) This Electric Wheelchair 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) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov > "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4} 510(k) Summary K250475 Document Prepared Date: 04/30/2025 1. Applicant Company name: NINGBO BAICHEN MEDICAL DEVICES CO., LTD Address: Room 2101, No.666 Taikang Middle Road, Yinzhou District, Ningbo City, Zhejiang, 315000, CHINA Contact Person: Mr. Wu Xiaolong Tel: alan@baichen.ltd Submission Correspondent: Primary Contact: Luna Hu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: 0086-21-58817802 Email: liu.hu@sungoglobal.com Secondary Contact: Raymond Luo Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: 0086-21-68828050 Email: zxfda@sungoglobal.com 2. Device Trade name: Electric Wheelchair Classification name: Powered wheelchair Model: BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3 Regulatory Information Classification: Class II Product code: ITI Regulation Number: 890.3860 Review Panel: Physical Medicine 3. Predicate Device Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co., Ltd. Product Name: Power wheelchair (Model: W5538) 510(K) #: K242471 {5} NINGBO BAICHEN MEDICAL DEVICES CO., LTD ## 4. Indication for Use This Electric Wheelchair 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. ## 5. Device Description The product is intended only carry one person and used as a means of transportation for the old and infirm who have difficulty in moving. The maximum occupant mass is 100kg. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, Battery charger socket), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices. The wheelchair can easily fold and unfold for transportation or storage. ## 6. Non-clinical Test Conclusion Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - ISO 10993-1: 2018 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process - ISO 7176-1:2014, Wheelchairs - Part 1: Determination of static stability - ISO 7176-2:2017, Wheelchairs - Part 2: Determination of dynamic stability of electrically powered wheelchairs - ISO 7176-3:2012, Wheelchairs - Part 3: Determination of effectiveness of brakes - ISO 7176-4:2008, 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 overall dimensions, mass and manoeuvring space - ISO 7176-6:2018, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electrically powered 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 strengths - 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 {6} NINGBO BAICHEN MEDICAL DEVICES CO., LTD > ISO 7176-13:1989, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces > ISO 7176-14:2008, 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 7176-25:2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs > 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, and battery chargers > IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests > IEC 62133-2: 2017: 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 # 7. Clinical Test Conclusion No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the electric wheelchair to its predicate device. 8. Comparison technological characteristics with the predicate device | Attribute | Subject device | Predicate device | Results | | --- | --- | --- | --- | | 510(k) number | K250475 | K242471 | / | | Manufacturer | NINGBO BAICHEN MEDICAL DEVICES CO., LTD | Zhejiang Innuovo Rehabilitation Devices Co., Ltd. | / | | Proprietary name, model | Electric Wheelchair BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3 | Power Wheelchair W5538 | / | | Device classification name | Class II | Class II | Same | | Classification regulations | 21 CFR 890. 3860 | 21 CFR 890. 3860 | Same | | Product code | ITI | ITI | Same | | Indication for use | This Electric Wheelchair 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. | The Power Wheelchair 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. | Same | | Intended user | disabled people with mobility difficulties and elderly people | disabled people with mobility difficulties and elderly people | Same | {7} NINGBO BAICHEN MEDICAL DEVICES CO., LTD | Use condition | indoor and outdoor use | indoor and outdoor use | Same | | --- | --- | --- | --- | | Number of wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | Same | | Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction Anti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. Non-adjustable. | Front wheels: driven wheels suitable for rotation, acceleration, retrograde Rear wheels: driving wheels to control the speed and direction Anti-tip wheels: preventing the wheelchair from tipping turning over when driving on the slope. Non-adjustable. | Same | | Movement control method | By Joystick control | By Joystick control | Same | | Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | Same | | Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | Same | | Motor | Brushless DC motor; 24VDC; 250W; 2pcs | Brushless DC motor; 24VDC; 250W; 2pcs | Same | | Differences | | | | | Main frame material | BC-EA5516 and BC-EALD3: Aluminium alloy with ABS coating BC-EC8002 and BC-EC8003: Carbon fiber with PUR coating | Magnesium alloy material | D#1 | | Total mass | BC-EA5516: 27kg BC-EC8002: 20kg BC-EC8003: 16kg BC-EALD3: 20kg | 19kg | D#2 | | Front wheel size/type | BC-EA5516: Solid tire, 8 inch BC-EC8002: Solid tire, 6 inch BC-EC8003: Solid tire, 6 inch BC-EALD3: Solid tire, 8 inch | 6.8" x 1.3"/PU Solid tire | D#3 | | Rear wheel size/type | BC-EA5516: Pneumatic tire, 12 inch BC-EC8002: Solid tire, 8 inch BC-EC8003: Solid tire, 11 inch BC-EALD3: Solid tire, 12 inch | 10.5"x 1.4"/ PU Solid tire | | | Max speed forward (km/h) | BC-EA5516: 6.48 BC-EC8002: 6.48 BC-EC8003: 5.76 BC-EALD3: 6.84 | Up to 6.1 km/h (1.7 m/s) | D#4 | {8} NINGBO BAICHEN MEDICAL DEVICES CO., LTD | Max speed backward (km/h) | BC-EA5516: 3.24 BC-EC8002: 3.24 BC-EC8003: 2.88 BC-EALD3:3.24 | Less than 3 km/h (0.6m/s) | | | --- | --- | --- | --- | | Maximum safe operational incline degree | BC-EA5516, BC-EC8002 and BC-EC8003: 10° | 10° | Same | | | BC-EALD3: 6° | | D#5 | | Braking distance | BC-EA5516: 1.2m BC-EC8002: 1.2m | 1.2m | Same | | | BC-EC8003: 0.7m BC-EALD3: 0.6m | | D#6 | | Battery | li-ion battery pack; rechargeable BC-EA5516: 24V12Ah BC-EC8002: 24V12Ah | li-ion battery pack; rechargeable, 24 VDC 12Ah | Same | | | BC-EC8003: 24V10Ah BC-EALD3:XWE2410-B | | D#7 | | Battery charger | Off-board charger Input: 100-240V, 50/60Hz, 1.5A Output: 24 V, 2A | Off-board charger Input: 100-240V, 50/60Hz, 1.1A Output: 24 V, 2A | D#8 | | Max loading weight | 100kg | 120kg | D#9 | | Maximum distance of travel on the fully charged battery (km) | BC-EC8003: 15 | 15 | Same | | | BC-EA5516: 15.7 BC-EC8002: 15.3 BC-EALD3: 18.1 | | D#10 | | Electronic controller | SYC-PM30 Controller | DZWN2435-BWL Controller | D#11 | | Turning Radius (mm) | BC-EA5516: 1000 BC-EC8002: 850 BC-EC8003: 950 BC-EALD3: 850 | 900 | D#12 | | Maximum obstacle climbing (mm) | BC-EA5516: 40 BC-EC8002, BC-EC8003 and BC-EALD3: 20 | 25 | D#13 | ## Difference analysis: D#1: Different material used for frame, that such difference will not impact the safety and effectiveness of the subject device as the performance tests are conducted according to ISO 7176 series. D#2: Different frame material caused different weight of the wheelchair. This difference will not raise any new safety and effectiveness concerns. D#3: Minor difference on dimension of driven wheel will not cause different performance. {9} NINGBO BAICHEN MEDICAL DEVICES CO., LTD D#4: Minor difference on max. forwarding and back warding speeds will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. D#5: Minor difference on safe operational incline degree will not cause new safety and effectiveness concerns are raised as both the static and dynamic stability under specific inclining degree have been evaluated according to standard ISO 7176 series. D#6: Minor difference on braking distance will not cause different performance. Shorter distance for braking will be more safety. D#7: Minor difference on battery capacity will not cause different performance. This difference will not raise any new safety and effectiveness concerns. D#8: Minor difference on the input current of the charger which will not cause new safety and effectiveness concerns raised. D#9: Minor difference on loading weight will not cause different performance. All safety and performance have been validated according to ISO 7176 series. D#10: Minor difference on travel distance will not cause different performance. This difference will not raise any new safety and effectiveness concerns. D#11: Similar controller is used, both the control system, including the joystick controller, the electromagnetic brakes and the user interface are similar. The joystick controls the directions and speed of movement, and when the joystick is released, the powered wheelchair will slow down to stop and the brakes will automatically re-engage. The controller also provides the battery status displaying and abnormal condition displaying. Both of the control systems are evaluated according to standard ISO 7176-14 and software validation requirement and there are no new safety and effectiveness concerns due to the difference. D#12: The minor difference in the turning radius is caused by different size of wheelchair and may cause a little bit inconvenience when it turns in a narrow space while the minor difference will not raise any new safety and effectiveness concerns. D#13: Minor difference in the obstacle climbing will not impact the safety and effectiveness of the subject device. ## 9. Summary of substantial equivalence discussion The electric wheelchair complied with the requirements of ISO 7176-1:2014, ISO 7176-2:2017, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008, ISO 7176-6:2018, ISO 7176-7:1998, ISO 7176-8:2014, ISO 7176-9:2009, ISO 7176-10:2008, ISO 7176-11:2012, ISO 7176-13:1989, ISO 7176-14:2022, ISO 7176-15:1996, ISO 16840-10:2021, ISO 7176-21:2009, ISO 7176-22:2014, ISO10993-1:2018, IEC60601-1-2: 2020. The indications for use for both devices are the same. Mainframes of two devices are folded by way of front and rear close. The design principles of the controller and Driving system are the same, and both meet the requirements of the ISO 7176-14. Software validation is carried out on both control systems. Brake system and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3. Turning radius, maximum obstacle climbing and Maximum safe operational incline are slightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-2 and ISO 7176-10. The flame-retardant test of the seat cushion/ backrest of both subject device and predicate device is carried out according to the ISO 16840-10 test. Therefore, both devices are assured to be under the same safety level. {10} NINGBO BAICHEN MEDICAL DEVICES CO., LTD In conclusion, the technological characteristics, features, specifications, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. ## 10. Conclusion 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 K242471.