(99 days)
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.
The product is a wheelchair which provides transport for the elderly and mobility-impaired individuals.
The maximum loading weight of the device is 100kg.
The wheelchair is a battery powered four wheeled vehicle.
It consists one Li-ion Battery with an off-board battery charger, frame, controllers, motors, seat, back support, control device (including: Power on/off, battery power indicator, horn button, speed indicator, speed up/down button, charging port), two rear wheels, two front wheels, foot support.
The wheelchair can easily fold for transportation or storage.
N/A
FDA 510(k) Clearance Letter - Electric Wheelchair (E201)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.03
March 24, 2026
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
℅ Eva Li
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai, 200122
China
Re: K254012
Trade/Device Name: Electric Wheelchair (E201)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: December 9, 2025
Received: December 15, 2025
Dear Eva Li:
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"
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K254012 - Eva Li 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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 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 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).
Page 3
K254012 - Eva Li Page 3
Sincerely,
Digitally signed by MARY S. KESZLER -S
Date: 2026.03.24
12:06:14 -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
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. K254012
Please provide the device trade name(s).
Electric Wheelchair (E201)
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)
Electric Wheelchair Page 11 of 40
Page 5
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
510(K) Summary
1. Applicant Information:
Name: Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
Address: 8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
Phone: 008615150675891
Contact Person: James Gu
Prepared date: March 17, 2026
2. Device
Trade Name: Electric Wheelchair(E201)
Regulatory Class: Class II
Product Code: ITI
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
3. Predicate Device:
510(K) Number: K250366
Device Name: Electric Wheelchair (LW01301A07)
4. Device description
The product is a wheelchair which provides transport for the elderly and mobility-impaired individuals.
The maximum loading weight of the device is 100kg.
The wheelchair is a battery powered four wheeled vehicle.
It consists one Li-ion Battery with an off-board battery charger, frame, controllers, motors, seat, back support, control device (including: Power on/off, battery power indicator, horn button, speed indicator, speed up/down button, charging port), two rear wheels, two front wheels, foot support.
The wheelchair can easily fold for transportation or storage.
1 / 11
Page 6
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
5. 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
2 / 11
Page 7
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
6. Comparison of the Technological Characteristics with the Predicate Device
Table 1 - General Information Comparison
| Item | Subject Device (K254012) | Predicate Device (K250366) | Discussion/Conclusion |
|---|---|---|---|
| Product Code | ITI | ITI | Same |
| Regulation No. | 21 CFR 890.3860 | 21 CFR 890.3860 | Same |
| Device classification | Class II | Class II | Same |
| Product Name | Electric Wheelchair | Electric Wheelchair | Same |
| Model(S) | LW01301A07 | E201 | Different, the model difference will not raise safety and effectiveness concerns to the device. |
| 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. | 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 Environment | Indoor and outdoor use | Indoor and outdoor use | Same |
| Patient Population | The device is suitable for disabled people with mobility difficulties and elderly people. | The device is suitable for disabled people with mobility difficulties and elderly people. | Same |
| Product Structure | Consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, a piece of Li-ion battery pack, an off-board battery charger, a control panel, and an electric motor controller. | Consist of two foldable armrests, a backrest, a seat cushion, a safety belt, a foldable frame, two rear driving wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel, and an electric motor controller. | Same |
3 / 11
Page 8
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
| Item | Subject Device (K254012) | Predicate Device (K250366) | Comparison |
|---|---|---|---|
| Driving System | Direct drive on the rear wheels | Direct drive on the rear wheels | Same |
| Number of wheels | 4 | 4 | Same |
| Motor | Brushless DC motor; 24VDC; 250W; 2pcs | Brushless DC motor; 24VDC; 250W; 2pcs | Same |
| Battery | Lithium-ion battery 24V 6Ah*2 | Li-ion battery pack; rechargeable, 24 VDC 13Ah | Analysis: Minor difference in battery does not impact safety and effectiveness. The battery has been tested according to IEC 62133 standard. |
| Battery Charger | Off-board charger Input: 100-240VAC, 50/60Hz, 1.5A Output: 24V, 2.0A | Off-board charger Input: 100-240VAC, 50/60Hz, 1.5A; Output: 24V, 2.0A | Same |
| Main Frame Material | Aluminum Alloy | Aluminum Alloy | Same |
| Armrest | PU | PU | Same |
| Seat cushion&Back cushion | Polyethylene terephthalate (PET) | Nylon | Different, this difference does not impact safety and effectiveness. |
| 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 |
Table 2 - Technical Parameters Comparison
| Item | Subject Device (K254012) | Predicate Device (K250366) | Comparison |
|---|---|---|---|
| Overall dimension (LWH) | 1120620380(mm) | 11206401000mm | Different, this difference does |
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Page 9
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
not impact safety and effectiveness.
5 / 11
Page 10
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
| Item | Subject Device (K254012) | Predicate Device (K250366) | Comparison |
|---|---|---|---|
| Folded Dimension (LWH) | 810600380(mm) | 760640460mm | Different, this difference does not impact safety and effectiveness. |
| Front wheel size/type | 8 inch PU Solid tire | 8 inch PU Solid tire | Same |
| Real wheel | 12 inch PU Solid tire | 12 inch PU Pneumatic tire | Different, this difference does not impact safety and effectiveness. |
| Braking distance | 1.2m | 1.2m | Same |
| Maximum safe operational incline degree | 6° | 6° | Same |
| Max speed forward | Up to 6.84 km/h (1.9 m/s), adjustable | Up to 6.84 km/h (1.9 m/s), adjustable | Same |
| Max speed backward | 2.88km/h(0.8m/s) | Less than 3.96 km/h (1.1 m/s) | Different, this difference does not impact safety and effectiveness. |
| Max loading weight | 100kg | 120kg | Different, this difference does not impact safety and effectiveness. |
| Maximum distance of travel on the fully charged battery | 15.3km | 17.6 km | Different, this difference does not impact safety and effectiveness. |
| Turning Radius | 975mm | 958mm | Different, this difference does not impact safety and effectiveness. |
| Maximum obstacle climbing | 40mm | 30mm | Different, this difference does not impact safety and effectiveness. |
Substantial Equivalence Discussion:
The proposed E201 Electric Wheelchair complies 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 7176-11:2008, ISO 7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 7176-16/ISO 16840-10, ISO 7176-21:2009, ISO 7176-22:2014, ISO 7176-25:2013, IEC 60601-1-2:2020, IEC TR 60601-4-2:2016, ISO 10993-1:2018, ISO10993-5:2009, ISO 10993-10:2021 and ISO 10993-23:2021.
6 / 11
Page 11
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
The instructions for use, design and technological characteristics of the subject Electric Wheelchair are similar to the predicate device. The design principles of the controller and driving system are the same, and both meet the requirements of the ISO 7176-14:2008. Software validation has been 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 7176-3:2012. There are minor differences in the subject device including the Battery, Seat cushion, Back cushion, Overall dimensions, Folded dimensions, Rear wheel material, Max speed backward, Max loading weight, Maximum distance of travel on the fully charged battery, Turning radius, and Maximum obstacle climbing. However, all differences have been tested according to ISO 7176 series standards and the test records support its safety and effectiveness. These differences do not impact safety and effectiveness. In conclusion, the subject device is substantially equivalent to the cited predicate device (K250366).
Table 3 - Safety Comparison
| Item | Subject Device (K254012) | Predicate Device (K250366) | Discussion/Conclusion |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-5, ISO10993-10 and ISO10993-23 requirements. | Complies with ISO 10993-1, FDA Guidance | Same |
| EMC | IEC 60601-1-2& ISO7176-21 | IEC 60601-1-2& ISO7176-21 | Same |
| Performance | ISO7176 series | ISO7176 series | Same |
| Label and labeling | Conforms to FDA Regulatory requirements | Conforms to FDA Regulatory requirements | Same |
7 / 11
Page 12
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
| Item | Subject Device (K254012) | Predicate Device (K250366) | Discussion/Conclusion |
|---|---|---|---|
| ISO 7176-1 | 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 |
8 / 11
Page 13
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
| Item | Subject Device (K254012) | Predicate Device (K250366) | Discussion/Conclusion |
|---|---|---|---|
| ISO 7176-2 | 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 |
| ISO 7176-3 | 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 |
| ISO 7176-4 | 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 |
| ISO 7176-5 | The dimensions and mass of the wheelchairs have been determined after the testing according to the ISO 7176-5. | The dimensions and mass of the wheelchairs have been determined after the testing according to the ISO 7176-5. | Same |
| ISO 7176-6 | The maximum speed has been determined after the testing according to the ISO 7176-6. | The maximum speed has been determined after the testing according to the ISO 7176-6. | Same |
| ISO 7176-7 | The seating and wheel dimensions have been determined after the testing according to the ISO 7176-7 | The seating and wheel dimensions have been determined after the testing according to the ISO 7176-7 | Same |
| ISO 7176-8 | 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 |
| 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. | 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 |
| ISO 7176-10 | The obstacle-climbing ability of device has been determined after the | The obstacle-climbing ability of device has been determined | Same |
9 / 11
Page 14
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
| Item | Subject Device (K254012) | Predicate Device (K250366) | Discussion/Conclusion |
|---|---|---|---|
| testing according to the ISO 7176-10. | after the testing according to the ISO 7176-10. | ||
| ISO 7176-11 | 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 |
| ISO 7176-13 | 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 |
| 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. | All test results meet the requirements in Clause 7, 8, 9, 10, 11, 12, 13, 14, 15, 17 of ISO 7176-14. | Same |
| ISO 7176-15 | 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 |
| ISO 7176-16/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 |
| ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | The performance of batteries and chargers for powered wheelchairs meet the requirements of ISO 7176-25 | Same |
7. Non-clinical performance
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Software validation
- ISO7176-1 :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- Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
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Page 15
Nanjing CareMoving Rehabilitation Equipment Co.,Ltd
8701, 8707, Building A4, No.128 Jiangjun Avenue, Jiangning District, Nanjing, Jiangsu, China.
- 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
- ISO7176-7:1998 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
- ISO7176-11 :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.
- ISO16840-10:2021 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
- ISO7176-22 : 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 60601-1-2:2020.
- Battery testing in according with IEC 62133-2: 2017+A1:2021
8. Clinical performance
None.
9. Conclusion
Based on the comparison and analysis above, the subject device is substantially equivalent to the predicate device (K250366).
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§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).