(251 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.
This product consists of frame, wheels, seat, armrest, backrest, headrest, battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The backrest, headrest and armrest can be adjustable. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lead-acid batteries as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is steel and aluminum. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.
The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 135KG. Only for one person sit.
N/A
FDA 510(k) Clearance Letter - K251159
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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.02
December 22, 2025
Zhenjiang Assure Medical Equipment Co., Ltd.
℅ Ariel Xiang
Consultant
Shanghai Sungo Management Consulting Co. Ltd.
14th Floor, 1500# Century Avenue
Shanghai, Shanghai 200122
China
Re: K251159
Trade/Device Name: Power wheelchair
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: November 21, 2025
Received: November 21, 2025
Dear Ariel Xiang:
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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(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-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).
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Sincerely,
Tushar Bansal -S
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
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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): K251159
Device Name: Power wheelchair
Indications for Use (Describe)
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.
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:
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"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."
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ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
NO.297, CHUQIAO ROAD, ZHENJIANG CITY, JIANGSU PROVINCE,CHINA
510(K) Summary
K251159
Document Prepared Date: 2025/04/14
A. Applicant
Name: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD.
Address: NO.297, CHUQIAO ROAD, ZHENJIANG CITY, JIANGSU PROVINCE,CHINA
Contact Person: Mei Ying
Email: shelly@assuremedical.com.cn
B. Device
Trade Name: Power wheelchair
Common Name: Electric wheelchair
Models: EL-001
Regulatory Information
Classification Name: Powered wheelchair
Classification: Class II.
Product code: ITI
Regulation Number: 890.3860
Review Panel: Physical Medicine
C. Predicate device
K244003
Electrically powered wheelchair, HP330
Kunshan Hi-Fortune Health Products Co., Ltd.
D. Indications for use of the device
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.
E. Device Description
This product consists of frame, wheels, seat, armrest, backrest, headrest, battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded and it can be easily carried or rolled after folding. The backrest, headrest and armrest can be adjustable. Users can drive the wheelchair by themselves through the control device.
The wheelchair uses lead-acid batteries as its power source. The controller controls the drive
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left/right motor to realize the wheelchair forward, backward and turn functions.
The frame of the device is steel and aluminum. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.
When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.
The DC brushless motor and brake system are fixed on the rear wheels.
The max loading of the device is 135KG. Only for one person sit.
F. Comparison to predicate device
Table 1 General Comparison
| Elements of Comparison | Proposed Device (K251159) | Predicate Device (K244003) | Remark |
|---|---|---|---|
| Manufacturer | ZHENJIANG ASSURE MEDICAL EQUIPMENT CO., LTD. | Kunshan Hi-Fortune Health Products Co., Ltd | -- |
| Common or Usual name | Power wheelchair | Electrically powered wheelchair | -- |
| Model(s) | EL-001 | HP330 | -- |
| Classification | Class II | Class II | Same |
| Classification regulation | 21 CFR890.3860 | 21 CFR890.3860 | Same |
| Product code | ITI | ITI | Same |
| 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. | SE. |
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| Use condition | indoor and outdoor use | indoor and outdoor use | SE |
|---|---|---|---|
| Number of wheels | 6, including two front wheels and two rear wheels, two anti-tip wheels | 6, including two front wheel and two rear wheels, two anti-tip wheels | SE |
| Function of wheels | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheels to control the speed and Direction | Front wheels: driven wheels suitable for rotation, acceleration, retrogradeRear wheels: driving wheels to control the speed and Direction | SE |
| Movement control method | By Joystick control | By Joystick control | SE |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | SE |
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | SE |
| Braking distance | ＜1m | ≤1.5m | SE |
| Brake time | ＜1s | ＜1s | SE |
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| Armrest | Polyurethane | Polyurethane | SE |
|---|---|---|---|
| Max loading weight | 135kg | 136kg | SE |
| Maximum safe operational incline degree | 6° | 6° | SE |
| Back cushion | Polyurethane | Polyurethane | SE |
| Seat cushion | Polyurethane | Polyurethane | Similar,Different materials will not affect safety and performance of the Proposed device as all related stability tests are performed according to standard ISO 7176 series. |
| Main frame material | Steel+Aluminum | Carbon steel material | |
| Overall Dimension (lengthwidthheight) | 1132mm590mm1086mm | 950mm660mm950mm | Minor difference on wheelchair dimension will not cause different performance. All safety and |
| Folded Dimension (lengthwidthheight) | 820mm590mm808mm | 740mm600mm410mm |
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| performance have been validated with the maximum rated weight dummy. | |||
|---|---|---|---|
| Front wheel size/type | 9 " | 6 " | Different sizes and materials will not affect safety and performance of the proposed device as all related stability tests are performed according to standard ISO 7176 series. |
| Rear wheel size/type | 13 " | 10 " | |
| Maximum speed forward | 6 km/h (1.7 m/s) | Up to 5.4km/h （1.5 m/s） | Similar,Both the Proposed device and The predicate device complys with ISO 7176-6:2018 Wheelchairs - Part 6: Determination |
| Maximum Speed backward | Less than 3.24 km/h (0.9m/s) | Less than 2.5km/h (0.7m/s) |
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| of maximum speed, acceleration and deceleration of electric wheelchairs, so these differences do not affect safety and effectiveness. | |||
|---|---|---|---|
| Maximum distance of travel on the fully charged battery | 30.6km | 12km | Different, will not cause new safety and effectiveness concerns. |
| Battery | Lead-acid battery;rechargeable, 12 VDC 50Ah*2 | Lead-acid Battery,;rechargeable; 12V 22AH*2 | Both meet the requirements of the ISO 7176-25：2013 Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs..It will not cause new safety |
| Battery charger | Input: 100-240V. 50/60Hz, 2.2-1.1A. Output: 24 V, 5A Off-board charger | Input:100-240VAC,50-60Hz,1.2-0.5A Output:24V,2A |
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| and effectiveness concerns. | |||
|---|---|---|---|
| Motor | Brushless DC motor; 24VDC; 350W; 2pcs | Brushless DC motor; 24VDC; 250W; 2pcs | Similar, Both meet the requirements of the ISO 7176-14. It will not cause new safety and effectiveness concerns. |
| Electronic controller | Dynamic, | Dynamic, | |
| Turning Radius | 900mm | 825mm | Minor difference in turning radius is caused by different size of wheelchair and may |
| Obstacle climbing height(forward) | 40mm | 25mm | Minor difference on obstacle climbing will not cause new safety and effectiveness concerns. |
Table 2 safety comparison
| Item | Proposed Device | Predicate Device | Results |
|---|---|---|---|
| Biocompatibility | All user directly contacting materials are compliance with ISO10993-1, ISO10993-5, ISO10993-10 and ISO10993-23 requirements. | All user directly contacting materials are compliance with ISO10993-1, ISO10993-5, ISO10993-10 and ISO10993-23 requirements. | SE |
| EMC | ISO7176-21/ IEC 60601-1-2/ IEC TR 60601-4-2 | ISO7176-21/ IEC 60601-1-2/ IEC TR 60601-4-2 | SE |
| Performance | 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 7176-22, ISO 7176-25 | 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 7176-22, ISO 7176-25 | SE |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | SE |
G. 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, ISO 7176-25, and FDA guidance Submission for Power Wheelchair.
The indications for use for both devices are the same. 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.
The frame materials,turning radius, and maximum obstacle climbing are slightly different while such differences will not impact the safety and effectiveness of the proposed device or raise new safety and effectiveness concerns as well as both meet the requirements of the ISO 7176-8 and ISO 7176-10.
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The biocompatibility of the predicate device and proposed device meet the requirements of the ISO 10993-5:2009 & ISO 10993-10:2021 & ISO 10993-23: 2021.
The flame-retardant test of the seat cushion/ backrest of both proposed 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.
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 proposed device and predicate devices do not raise new issues of safety or effectiveness.
H. Product Performance
Product Material Safety
To ensure the safety of the wheelchair material, the bio-compatibility testing was done to the products. The testing was conducted according to the following standards:
- ISO10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO10993-5 Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation
From the test result, we can find the material are safety and can meet the requirements.
Performance of the products
The following performance data were provided to verify that the proposed device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971: 2019.
- Software validation
- ISO 7176-1:2014 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
- 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
- ISO 7176-7:1998 Wheelchairs - Part 7: Measurement of seating and wheel dimensions
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- 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
- ISO 7176-11:2012 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.
- 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
- ISO 7176-22：2014 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 and IEC TR 60601-4-2
I. Conclusion
The proposed device and the predicate products have the same technological characteristics, features, specifications, materials, mode of operation, and intended use of the device. To ensure all the key characteristic of the products can meet the requirements, the testing was done and all the results indicate the positive conclusion.
Based on the analysis above, we confirm these two products are essentially equivalent.
§ 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).