Electric Wheelchair (HG-630)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION July 2, 2025 Zhejiang Automwheel Tech Co., Ltd. % Kiwi Xu Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai, 200122 China Re: K251285 Trade/Device Name: Electric Wheelchair (HG-630) Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 13, 2025 Received: June 13, 2025 Dear Kiwi Xu: 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} K251285 - Kiwi Xu 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} K251285 - Kiwi Xu 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, Julia E. 2025.07.02 Slocomb -S 16:40:42 -04'00' 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 {3} Electric Wheelchair Page 10 of 51 | 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. | K251285 | ? | | Please provide the device trade name(s). | | ? | | Electric Wheelchair (HG-630) | | | | 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 (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China # 510k summary K251285 ## Submitter: Name: Zhejiang Automwheel Tech Co., Ltd. Address: 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China Contact: Zhihao Liu Email: info@automwheel.com ## Device: Device Name: Electric Wheelchair Model: HG-630 Classification name: Powered wheelchair Regulation class: 2 Regulation number: 21CFR 890.3860 Panel: Physical Medicine Product code: ITI ## Predicate device: 510Knumber: K240913 Device Name: Electric Wheelchair Model: HBLD3-B, HBLD3-E Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd ## Device description: The subject device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use. The Electric Wheelchair is a battery powered four wheeled vehicle. It consists lead-acid battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel 1 of 6 {5} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels. The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Electric Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling. The Electric Wheelchair has 7 inch front wheel and 12 inch rear tire. Max. distance of travel on the fully charged battery is 13.3 km and Max. speed forward is 5.76 km/h. When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake. The braking time is about 2s, and the braking distance is ≤1.5m. ## Indication for use: 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. ## Product Parameter Table 1 General Comparison | Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark | | --- | --- | --- | --- | | Manufacturer | Zhejiang Automwheel Tech Co., Ltd. | Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd | - | | Common or Usual name | Power Wheelchair | Power Wheelchair | Same | | Model(s) | HG-630 | HBLD3-B, HBLD3-E | -- | {6} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China | Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark | | --- | --- | --- | --- | | Indications 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. | 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. | Same | | Use condition | indoor and outdoor use | indoor and outdoor use | Same | | Number of wheels | 4, including two front wheels and two rear Wheels | 4, including two front wheels and two rear Wheels | Same | | Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrograde. Rear wheels: driving wheels to control the speed and direction | Front wheels: driven wheels suitable for rotation, acceleration, retrograde. Rear wheels: driving wheels to control the speed and direction | 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 electronic brake system | Automatic electromagnetic brake system | Same | | Braking distance | ≤0.8 m | ≤1.5 m | Analysis: Larger braking distance and safe operational incline degree of subject bring more convenient for the use environment. | | Maximum safe operational incline degree | 10 ° | 6 ° | | | Armrest | PU (polyurethane) | ABS | Analysis: Difference of the materials will not raise safe and effectiveness concerns. The biocompatibility tests have been conducted to verify the safety and effectiveness of the material. | | Battery charger | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 V-29.6V, 1.8A; | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | Same | {7} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China | Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark | | --- | --- | --- | --- | | Main frame material | Aluminum alloy | Aluminum Alloy | Same | | Seat cushion | Polyester fiber | Polyester fabric | Same | | Back cushion | Polyester fiber | Polyester fabric | Same | | Overall Dimension (length*width*height) | 1070×560×870 mm | HBLD3-B model: 960×580×890 mm HBLD3-E model: 1090×640×900 mm | Analysis: Minor differences in the dimensions will not impact the safety and effectiveness of the substantial equivalence. | | Folded Dimension (length*width*height) | 710×370×750 mm | HBLD3-B model: 890×600×380 mm HBLD3-E model: 730×350×950 mm | | | Front wheel size/type | 8"/ Solid tyre | 7" x 1.75"/PU Solid tire | Analysis: Different sizes and type of rear wheel will not affect the safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176 series. | | Rear wheel size/type | 12" x 1.75"/ Solid tyre | 12" x 2.125" pneumatic tire | | | Max speed forward | 5.76 km/h(1.6 m/s) | 6-8 km/h (1.6-2.2 m/s), adjustable | Analysis: Slightly difference on the parameter will not affect the safety and performance of the subject device as all related stability tests are performed according to standard ISO 7176-6:2018. | | Max Speed backward | Less than 3.6 km/h (1.0 m/s) | Less than 3 km/h (0.8m/s) | | {8} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China | Elements of Comparison | Subject Device | Predicate Device (K240913) | Remark | | --- | --- | --- | --- | | Max loading weight | 100 kg | 100 kg | Same | | Battery | 12V 12Ah Lead-acid battery×2 | Li-ion battery pack; rechargeable, 24 V DC 5.2 Ah*2 | Analysis: The subject device complies with ISO 7176-25: 2013 Wheelchairs -Part 25: Batteries and chargers for powered wheelchairs and EMC testing, these differences do not affect safety and effectiveness. | | Maximum distance of travel on the fully charged battery | 13.3km | 20km | Analysis: The subject device complies with ISO 7176-4: 2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range, these differences do not affect safety and effectiveness. | | Motor | DC motor; 24VDC; 250W; 160 r/min | Brushless DC motor; 24VDC; 150W; 2pcs | | | Electronic controller | Brushless dual-drive rocker controller | Brushless dual-drive rocker controller | Same | | Turning Radius | 925mm | HBLD3-B model: 875 mm HBLD3-E model: 1050 mm | Analysis: The predicate device and subject device have different dimensions. Both comply with ISO 7176-5:2008 Wheelchairs – Part 5: Determination of dimensions, mass, and maneuverings space so these differences do not affect safety and effectiveness. | | Maximum obstacle climbing | 25mm | 20mm | | 5 of 6 {9} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China Table 2 Safety comparison | Item | Proposed Device | Predicate Device | Results | | --- | --- | --- | --- | | Biocompatibility | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO 10993-23 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | Same | | EMC | ISO7176-21 & IEC 60601-1-2 | ISO7176-21 & IEC 60601-1-2 | Same | | Performance | ISO7176 series | ISO7176 series | Same | | Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | Same | | Item | Proposed Device | Predicate Device | Results | | --- | --- | --- | --- | | ISO7176-1 | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | The Static stability has been determined after the testing according to the ISO 7176-1, and test results meet its design specification. | Same | | ISO7176-2 | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | The dynamic stability has been determined after the testing according to the ISO 7176-2, and test results meet its design specification. | Same | | ISO7176-3 | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification. | Same | | ISO7176-4 | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | The theoretical distance range has been determined after the testing according to the ISO 7176-4, and test results meet its design specification. | Same | | ISO7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | The dimensions, mass has been determined after the testing according to the ISO 7176-5 | Same | | ISO7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | The dimensions, mass has been determined after the testing according to the ISO 7176-6 | Same | | ISO7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7 | Same | | ISO7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | All test results meet the requirements in Clause 4 of ISO 7176-8 | Same | | ISO7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | The test results shown that the device under tests could continue to function according to manufacturer's specification after being subjected to each of the tests specified in Clause 8 of ISO 7176-9 | Same | {10} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China | Item | Proposed Device | Predicate Device | Results | | --- | --- | --- | --- | | ISO7176-10 | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | The obstacle-climbing ability of device has been determined after the testing according to the ISO 7176-10, | Same | | ISO7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11 | Same | | ISO7176-13 | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved | Same | | ISO7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14 | Same | | ISO7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15 | Same | | ISO7176-16/ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | The performance of resistance to ignition meet the requirements of ISO 16840-10 | Same | | ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | The EMC performance results meet the requirements of ISO 7176-21 | Same | ## Substantial Equivalence Discussion: The proposed device and predicate device are complying to the same ISO standards, ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-7, ISO 7176-8, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 16840-10, ISO 7176-21 and FDA guidance Submission for Power Wheelchair. The proposed device performs in a similar manner to the predicate device. All these tests have corresponding requirements/ control criteria following above mentioned standards. And the test results show that the subject product is substantially equivalent to the predicate device in performance. The performance testing demonstrates that the subject device is substantially equivalent to the predicate devices regarding Static ability (tipping angle), The Dynamic stability (Safe Gradient Maximum Gradient), Brake performance, Theoretical distance range, Dimension and weight, Maximum speed, Dimension of wheel Static, impact and fatigue strengths, Climatic tests, Obstacle-climbing ability, Dummy, friction of test surfaces, Power and control systems, Documentation and labeling, Resistance to ignition, Electromagnetic Compatibility and Electrical Safety, Batteries and chargers. 7 of 6 {11} Zhejiang Automwheel Tech Co., Ltd. 1208-9, Innovation Building No. 1000 Linjiang East Road, Bailongqiao Town, Wucheng District, Jinhua City, Zhejiang Province, China The biocompatibility of the Predicate device and Subject device meet the requirements of the ISO 10993-5:2009 & ISO10993-10:2010/ ISO 10993-23:2021. The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions. **Summary of clinical testing:** No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device. **Substantially Equivalency Conclusion:** Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate devices, K240913 Power Wheelchair from Shanghai Hubang Intelligent Rehabilitation Equipment Co., Ltd. 8 of 6