(97 days)
Not Found
No.
The device description focuses on mechanical and electrical components (motor, controller, battery, joystick) for basic mobility functions, directly controlled by the user. There is no mention of advanced computational capabilities, learning algorithms, or data processing for decision-making typically associated with AI. The 'Mentions AI, DNN, or ML' section also explicitly states 'Not Found'.
Yes.
The device is a power wheelchair designed to provide mobility to disabled or elderly individuals, which is a therapeutic function aimed at improving their quality of life and aiding in rehabilitation or managing a disability.
No
Explanation: The device is described as a motor-driven transportation vehicle designed to provide mobility for disabled or elderly individuals. Its functions are related to movement and transportation (forward, backward, turn), not to diagnosing medical conditions or diseases.
No
The device description clearly outlines hardware components such as a frame, wheels, seat, battery, motor, and controller, which are fundamental to its function as a motorized wheelchair. The performance studies also focus on hardware-related aspects like braking, stability, and strength, confirming it is not a software-only device.
No.
The device is a power wheelchair, a motor-driven transportation vehicle used for mobility, not designed for in vitro diagnostic examination of human specimens.
N/A
Intended Use / 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.
Product codes
ITI
Device Description
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame's material of model ZH-W001 and ZH-W002 is aluminium alloy,the model ZH-W003 is carbon steel. 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 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 motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
disabled or elderly person
Intended User / Care Setting
disabled or elderly person limited to a seated position. / indoor and outdoor
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
FDA 510(k) Clearance Letter - Electric Wheelchair
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 28, 2025
Zhejiang Cleisman Industry and Trade Co., LTD
℅ Ariel Xiang
Consultant
Shanghai Sungo Management Consulting Co. Ltd.
14th Floor, 1500# Century Avenue
Shanghai, Shanghai 200122
China
Re: K250158
Trade/Device Name: Electric Wheelchair (ZH-W001, ZH-W002, ZH-W003)
Regulation Number: 21 CFR 890.3860
Regulation Name: Powered Wheelchair
Regulatory Class: Class II
Product Code: ITI
Dated: March 14, 2025
Received: March 14, 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.
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K250158 - Ariel Xiang 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-
Page 3
K250158 - Ariel Xiang 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. Slocomb -S 2025.04.28 13:29:41 -04'00'
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250158
Device Name
Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003)
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:
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."
Page 5
Zhejiang Cleisman Industry and Trade Co.,LTD
Workshop No.3,Xiaoweiyuan,Dongtuo Block ‖,Lishui High-tech Zone,Xinbi Street,Jinyun County, Lishui,Zhejiang,China
1 / 7
510(K) Summary
Document Prepared Date: 2025/3/11
A. Applicant
Zhejiang Cleisman Industry and Trade Co.,LTD
Workshop No.3,Xiaoweiyuan,Dongtuo,Block ‖,Lishui High-tech Zone,Xinbi Street,Jinyun County, Lishui,Zhejiang,China
Contact Name：Chongjie Zheng
Tel: +86 15989510939
Mail:674751020@qq.com
Submission Correspondent:
Primary contact: Ms.Ariel Xiang
Title: Senior Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: shouqiu.xiang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
Title: Technical Director
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: zxfda@sungoglobal.com
B. Device
Trade Name: Electric Wheelchair
Common Name: Powered wheelchair
Models: ZH-W001,ZH-W002,ZH-W003
Regulatory Information
Classification Name: Powered wheelchair
Classification: Class II.
Product code: ITI
Regulation Number: 890.3860
Review Panel: Physical Medicine
C. Predicate device
510K number: K113463
power wheelchair, PL00l
SUZHOU KD Medical Appliance Co. Ltd.
Page 6
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D. Indications for use of the device
The 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.
E. Device Description:
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame's material of model ZH-W001 and ZH-W002 is aluminium alloy,the model ZH-W003 is carbon steel. 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 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 motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.
F. Comparison with predicate Device
Table 1 General Comparison
| Elements of Comparison | Proposed Device | Predicate Device (K230964) | Remark |
|---|---|---|---|
| Manufacturer | Zhejiang Cleisman Industry and Trade Co.,LTD | SUZHOU KD Medical Appliance Co. Ltd. | -- |
| Common or Usual name | Electric Wheelchair | Power Wheelchair | -- |
| Model(s) | ZH-W001,ZH-W002,ZH-W003 | PL00l | -- |
| 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 | S.E. |
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| limited to a seated position. | |||
|---|---|---|---|
| Intended user | disabled or elderly person limited to a seated position. | disabled or elderly person limited to a seated position. | S.E. |
| Use condition | indoor and outdoor use | indoor and outdoor use | S.E |
| Number of wheels | 4,including two front wheels and two rear Wheels | 4,including two front wheels and two rear Wheels | S.E |
| 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 | S.E |
| Movement control method | By Joystick control | By Joystick control | S.E |
| Driving system | Direct drive on the rear wheels | Direct drive on the rear wheels | S.E |
| Brake system | Automatic electromagnetic brake system | Automatic electromagnetic brake system | S.E |
| Braking distance | ZH-W001:≤1.2m ZH-W002:≤1.0m ZH-W003:≤1.0m | 1.5 m | Minor difference on braking distance will not cause different performance. Shorter distance for braking will be more safety. |
| Maximum safe operational incline degree | 10 ° | 9 ° | Minor difference on operational incline degree will not cause different performance. |
| Main frame material | ZH-W001:aluminium alloy ZH-W002:aluminium alloy ZH-W003:carbon steel | Aluminium alloy | S.E ZH:W003 is different.Different material used for frame, that such difference will not |
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| impact the safety and effectiveness of the subject device as the performance tests are conducted according to ISO 7176 series. | |||
|---|---|---|---|
| Armrest | PUR | PU | S.E |
| Back cushion | Nylon | PU foam covered by nylon fabric cloth | S.E |
| Seat cushion | Nylon | PU foam covered by nylon fabric cloth | S.E |
| Overall length | ZH-W001:1130mm ZH-W002:1020mm ZH-W003:1020mm | 880mm | Minor difference on wheelchair dimension will not cause different performance. All safety and performance have been validated with the maximum rated weight dummy. |
| Overall width | ZH-W001:660mm ZH-W002:600mm ZH-W003:600mm | 570mm | |
| Folded Dimension (lengthwidthheight) | ZH- W001:770mm650mm380mm ZH- W002:760mm600mm330mm ZH- W003:760mm600mm330mm | 750570400mm | |
| Front wheel size/type | ZH-W001:200mm50mm ZH-W002:190mm30mm ZH-W003:177mm*40mm | 6" x 2"/PU Solid tire | Minor difference on dimension of wheels will not cause different performance. |
| Rear wheel size/type | ZH-W001:317mm57mm ZH-W002:320mm35mm ZH-W003:272mm*40mm | 8″x 2.4″/ PU Solid tire | |
| Max speed forward | ZH-W001:1.8m/s ZH-W002:1.6m/s ZH-W003:1.6m/s | Up to 6 km/h (1.6 m/s), adjustable | Minor difference on max speed forward of wheels will not cause different performance. |
| Max speed backward | 0.5m/s(1.8 km/h) | 2.4 mph (3.84 km/h) | lower speed on max. backward speed will be more safety. |
| Max loading weight | 120kg (265lbs) | 114kg (251lbs) | Difference on loading weight will not cause different performance. All safety and performance |
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| have been validated with the maximum loading weight. | |||
|---|---|---|---|
| Maximum distance of travel on the fully charged battery | ZH-W001:14.3 km ZH-W002:13.8 km ZH-W003: 13.8km | 20 km | It is caused by the size of the wheel, will not cause different performance, The further away the better. |
| Battery | li-ion battery pack 24V,12Ah, li-ion battery pack; rechargeable, | 24 VDC 20Ah | the battery capacity will impact the travel distance, which will not cause new safety and effectiveness concerns raised. |
| Battery charger | Off-board charger Input: 100-240V, 50/60Hz, 1.5A, Output: 24 Vdc, 2A; | Off-board charger Input: 110-240V, 50-60Hz, Output: 24 Vdc, 2A; | S.E |
| Motor | Brushless DC motor, 24V,250W, 2pcs | Brushless DC motor; 24VDC; 180W; 2pcs | Minor difference on motor power. Both meet the require of ISO 7176-14 standard. It will not cause new safety and effectiveness concerns. |
| Electronic controller | Brushless dual-drive rocker controller;40A | Brushless dual- drive rocker controller | 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 when the joystick is released, the powered wheelchair will slow down to stop |
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| 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 7176-14:2008 and software validation requirement and there are no new safety and effectiveness concerns due to the difference. | |||
|---|---|---|---|
| Turning Radius | ZH-W001:938mm ZH-W002:875mm ZH-W003:875mm | 800 mm | Minor difference on turning radius will not cause new safety and effectiveness concerns. |
| Maximum obstacle climbing | 20mm | 30 mm | 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 ISO10993-5、ISO10993-10 and ISO10993-23 requirements. | All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements. | SE |
| EMC | IEC 60601-1-2&ISO7176-21 | IEC 60601-1-2&ISO7176-21 | SE |
| Performance | ISO7176 series | ISO7176 series | SE |
| Label and labeling | Conforms to FDA Regulatory | Conforms to FDA Regulatory | SE |
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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 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. 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.
H. Product Performance
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices, K113463 Power Wheelchair from SUZHOU KD Medical Appliance Co. Ltd.